Unpacking the FDA Approvals That Reshaped Cancer Care in 2025

In 2025, more than 60 agents and combinations, including biosimilars, earned accelerated, regular, or expanded approvals from the FDA, reshaping the treatment paradigms of multiple disease states and offering additional options for patients.

In the bladder cancer space, the FDA approval of the gemcitabine intravesical system (Inlexzo; TAR-200) in BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors, offers patients who previously had few options an effective treatment that can spare them from radical cystectomy. Linvoseltamab-gcpt (Lynozyfic) is now an off-the-shelf agent for heavily pretreated patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy. Moreover, the accelerated approval of zongertinib (Hernexeos) in adult patients with unresectable or metastatic nonsquamous non–small cell lung cancer whose tumors have HER2 tyrosine kinase domain–activating mutations signifies the first targeted therapy approved in the HER2-mutated space.

Over the course of 2025, experts spanning the breadth of tumor types participated in interviews with OncologyLive to share their insights on how the year’s notable FDA approvals will impact their practices. Their commentary, paired with the notable regulatory decisions in this spread, offers perspectives on the significance of these decisions.

Gastrointestinal Cancers

Sotorasib (Lumakras) plus panitumumab (Vectibix)

Month: January

Approval type: Regular

Indication: For the treatment of adult patients with KRAS G12C–mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-sotorasib-plus-panitumumab-for-kras-g12c-mutated-colorectal-cancer

“Approximately 4% of patients with mCRC have KRAS G12C mutations. The treatment [options] for those patients—similar to other patients with KRAS mutations—are quite limited after progression on fluoropyrimidine-, oxaliplatin-, and irinotecan-[based chemotherapy] and bevacizumab [Avastin]. The advent of a targeted therapy for [patients with mCRC harboring] KRAS G12C mutations with the combination of sotorasib and panitumumab, which has an updated overall response rate of [approximately] 30%, provides hope for these patients.” —Marwan G. Fakih, MD, City of Hope

Tislelizumab-jsgr (Tevimbra) plus platinum-containing chemotherapy

Month: March

Approval type: Regular

Indication: For the frontline treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) with a tumor PD-L1 expression of 1 or higher.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-first-line-tislelizumab-plus-chemotherapy-for-unresectable-or-metastatic-escc

“We should be able to incorporate this [regimen] into our treatment paradigms easily. Tislelizumab can be combined with different chemotherapy backbones and should be built into treatment guidelines for patients with ESCC.” —Nataliya Uboha, MD, PhD, University of Wisconsin School of Medicine and Public Health

Pembrolizumab (Keytruda) in combination with trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy

Month: March

Approval type: Regular

Indication: For the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-pembrolizumab-plus-trastuzumab-chemo-for-pd-l1-her2-gastric-gej-adenocarcinoma

Cabozantinib (Cabometyx)

Month: March

Approval type: Regular

Indication: For the treatment of patients 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extrapancreatic neuroendocrine tumors (epNET).

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-cabozantinib-for-pancreatic-and-extra-pancreatic-neuroendocrine-tumors

“To have an [FDA approval cover a] broad range of primary tumor sites is wonderful to see, as it also covers patients who have functional tumors or nonfunctional tumors, and those who may have somatostatin receptor–positive or –negative disease. There weren’t many restrictions in the approval, which means that it’s [now] a standard option for a large number of patients.”—Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute

Nivolumab (Opdivo) and ipilimumab (Yervoy)

Month: April

Approval type: Regular

Indication: For the treatment of patients 12 years and older with mismatch repair–deficient or microsatellite instability–high unresectable or metastatic colorectal cancer who have progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-nivolumab-plus-ipilimumab-for-dmmr-msi-h-metastatic-crc

Nivolumab (Opdivo) plus ipilimumab (Yervoy)

Month: April

Approval type: Regular

Indication: For the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-nivolumab-plus-ipilimumab-for-unresectable-or-metastatic-hepatocellular-carcinoma

Retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel

Month: May

Approval type: Regular

Indication: For the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA has also approved retifanlimab as monotherapy for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-retifanlimab-for-advanced-anal-cancer

SIR-Spheres Y-90 resin microspheres

Month: July

Approval type: Regular

Indication: For the treatment of patients with unresectable hepatocellular carcinoma.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-y-90-resin-microspheres-for-unresectable-hcc

Durvalumab (Imfinzi) for use in combination with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel)

Month: November

Approval type: Regular

Indication: As neoadjuvant and adjuvant treatment, followed by single-agent durvalumab, for adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-perioperative-durvalumab-for-resectable-gastric-gej-adenocarcinoma

Genitourinary Cancers

Durvalumab (Imfinzi) with gemcitabine and cisplatin

Month: March

Approval type: Regular

Indication: As neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adult patients with muscle-invasive bladder cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-perioperative-durvalumab-plus-chemo-for-muscle-invasive-bladder-cancer

Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)

Approval type: Expanded

Month: March

Indication: For the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-expands-indication-for-lutetium-lu-177-vipivotide-tetraxetan-in-mcrpc

“[The updated] approval expands the use [of lutetium Lu 177 vipivotide tetraxetan] from the very late context to the prechemotherapy setting—in today’s day and age, that means for first-line mCRPC.” —Michael J. Morris, MD, Memorial Sloan Kettering Cancer Center

Darolutamide (Nubeqa)

Month: June

Approval type: Regular

Indication: For the treatment of patients with metastatic castration-sensitive prostate cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-darolutamide-for-metastatic-castration-sensitive-prostate-cancer

Mitomycin intravesical solution (Zusduri; UGN-102)

Month: June

Approval type: Regular

Indication: For the treatment of adult patients with recurrent, low-grade, intermediate-risk, non–muscle-invasive bladder cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-intravesical-mitomycin-for-recurrent-low-grade-intermediate-risk-nmibc

Niraparib and abiraterone acetate (Akeega) plus prednisone

Month: December

Approval type: Regular

Indication: For the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-niraparib-abiraterone-acetate-plus-prednisone-for-brca2-mcspc

Rucaparib (Rubraca)

Month: December

Approval type: Regular

Indication: For the treatment of adult patients with BRCA mutation–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor–directed therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-full-approval-to-rucaparib-for-brca-mutation-associated-mcrpc

Gemcitabine intravesical system (Inlexzo; TAR-200)

Month: September

Approval type: Regular

Indication: For the treatment of adult patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis

“This is significant on many levels. On the first basic level, this is a population of patients who really have had no options in the past. They had some medicines that didn’t work very well, and then the alternative [treatment] would be radical cystectomy, which is a pretty significant surgery with its own quality-of-life changes.” —Joseph Jacob, MD, MCR, SUNY Upstate Medical University

Enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)

Month: November

Approval type: Regular

Indication: As neoadjuvant treatment followed by adjuvant treatment after cystectomy for patients with muscle-invasive bladder cancer who are ineligible for cisplatin.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-perioperative-enfortumab-vedotin-plus-pembrolizumab-for-cisplatin-ineligible-mibc

Leukemia

Treosulfan (Grafapex) plus fludarabine

Month: January

Approval type: Regular

Indication: As a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients 1 year and older with acute myeloid leukemia or myelodysplastic syndrome.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-treosulfan-for-allohct-conditioning-in-aml-and-mds

Revumenib (Revuforj)

Month: October

Approval type: Regular

Indication: For the treatment of patients 1 year and older with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who do not have satisfactory alternative treatment options.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-revumenib-for-relapsed-refractory-npm1-mutant-acute-myeloid-leukemia

Ziftomenib (Komzifti)

Month: November

Approval type: Regular

Indication:For the treatment of adult patients with relapsed/refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-ziftomenib-for-npm1-r-r-acute-myeloid-leukemia

Pirtobrutinib (Jaypirca)

Month: December

Approval type: Regular

Indication:For the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent Bruton tyrosine kinase inhibitor.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-pirtobrutinib-for-relapsed-or-refractory-cll-sll

Lymphoma

Acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan)

Month: January

Approval type: Regular

Indication: For the treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-acalabrutinib-plus-bendamustine-and-rituximab-for-previously-untreated-mcl

Brentuximab vedotin (Adcetris) plus lenalidomide (Revlimid) and rituximab (Rituxan)

Month: February

Approval type: Regular

Indication: For adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after 2 or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation or chimeric antigen receptor T-cell therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-brentuximab-vedotin-plus-lenalidomide-rituximab-for-r-r-lbcl

“With the exhaustion of some of the CD20- and CD19-targeting treatments, [brentuximab vedotin plus lenalidomide and rituximab] is important because it provides a different way of targeting the tumor. More therapies like this targeting different antigens will probably be seen in the future.” —Grzegorz S. Nowakowski, MD, FASCO, Mayo Clinic Comprehensive Cancer Center

Tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan)

Month: June

Approval type: Regular

Indication: For the treatment of adult patients with relapsed or refractory follicular lymphoma.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-tafasitamab-plus-lenalidomide-and-rituximab-for-r-r-follicular-lymphoma

Epcoritamab-bysp (Epkinly), rituximab (Rituxan), and lenalidomide (Revlimid)

Month: November

Approval type: Regular

Indication: For the treatment of patients with relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab monotherapy for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of therapy.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-epcoritamab-for-r-r-follicular-lymphoma

Mosunetuzumab-axgb (Lunsumio VELO)

Approval type: Regular

Month: December

Indication: As a subcutaneous formulation for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more prior lines of systemic therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-subcutaneous-mosunetuzumab-for-r-r-follicular-lymphoma

Lisocabtagene maraleucel (liso-cel; Breyanzi)

Approval type: Regular

Month: December

Indication: For the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-liso-cel-for-relapsed-refractory-marginal-zone-lymphoma

Additional Hematologic Malignancies

Linvoseltamab-gcpt (Lynozyfic)

Month: July

Approval type: Accelerated

Indication: For use in adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-linvoseltamab-for-relapsed-refractory-multiple-myeloma

“This approval provides a highly effective, off-the-shelf agent for the treatment of [patients with] relapsed/refractory multiple myeloma. There are some characteristics [that distinguish] linvoseltamab from other B-cell maturation antigen bispecific antibodies that will hopefully improve the access of this drug compared with some of the other agents that are available. In particular, there’s a lower hospitalization requirement for linvoseltamab, especially during this type of dosing, compared with some of the other agents.” —Hans Lee, MD, Sarah Cannon Research Institute

Belantamab mafodotin-blmf (Blenrep) in combination with bortezomib (Velcade) and dexamethasone

Approval type: Regular

Month: October

Indication: For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-belantamab-mafodotin-plus-bortezomib-and-dexamethasone-for-r-r-multiple-myeloma

Daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro)

Approval type: Regular

Month: October

Indication: For the treatment of adult patients with high-risk smoldering multiple myeloma.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-subcutaneous-daratumumab-for-high-risk-smoldering-multiple-myeloma

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), cyclophosphamide, and dexamethasone

Approval type: Regular

Month: November

Indication: For the treatment of patients with newly diagnosed light chain amyloidosis.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-daratumumab-and-hyaluronidase-fihj-in-newly-diagnosed-light-chain-amyloidosis

Narsoplimab-wuug (Yartemlea)

Approval type: Regular

Month: December

Indication: For the treatment of patients 2 years and older with hematopoietic stem cell transplant–associated thrombotic microangiopathy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-narsoplimab-hematopoietic-stem-cell-transplant-associated-thrombotic-microangiopathy

Non–Small Cell Lung Cancer

Telisotuzumab vedotin-tllv (Emrelis)

Month: May

Approval type: Accelerated

Indication: For the treatment of adult patients with locally advanced or metastatic, nonsquamous non–small cell lung cancer harboring high c-MET protein overexpression who have received a prior systemic therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-accelerated-approval-to-telisotuzumab-vedotin-in-pretreated-advanced-nsclc-with-c-met-overexpression

Taletrectinib (Ibtrozi)

Approval type: Regular

Month: June

Indication: For the treatment of patients with locally advanced or metastatic, ROS1-positive non–small cell lung cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-taletrectinib-for-ros1-advanced-nsclc

Datopotamab deruxtecan-dlnk (Dato-DXd; Datroway)

Month: June

Approval type: Accelerated

Indication: For adult patients with locally advanced or metastatic, EGFR-mutated non–small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-accelerated-approval-to-dato-dxd-for-egfr-nsclc

Sunvozertinib (Zegfrovy)

Month: July

Approval type: Accelerated

Indication: For the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or following platinum-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-accelerated-approval-to-sunvozertinib-for-nsclc-with-egfr-exon-20-insertion-mutations

Zongertinib (Hernexeos)

Month: August

Approval type: Accelerated

Indication: For adult patients with unresectable or metastatic nonsquamous non–small cell lung cancer whose tumors have HER2 tyrosine kinase domain–activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-accelerated-approval-to-zongertinib-for-nonsquamous-nsclc-with-her2-tkd-mutations

“HER2-mutant [non–small cell lung cancer] is one of the most aggressive and brain-metastatic subsets of lung cancer, and it is difficult to treat. It shares several biological features with EGFR-mutated disease, so we see limited efficacy with immunotherapies. The data sets are small, but what we know so far is that immunotherapy [in HER2-mutant disease] seems to produce response rates similar to [those in] EGFR-[mutant disease, which are] low. We’re mainly dependent on chemotherapy in this context, so introducing the first targeted therapy, [zongertinib], for HER2-mutant NSCLC is exciting.” —Martin F. Dietrich, MD, PhD, Cancer Care Centers of Brevard

Sevabertinib (Hyrnuo)

Month: August

Approval type: Accelerated

Indication: For the treatment of adult patients with locally advanced or metastatic, nonsquamous non–small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain–activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-accelerated-approval-to-sevabertinib-in-her2-mutated-nonsquamous-nsclc

Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro; subcutaneous amivantamab)

Approval type: Regular

Month: December

Indication: For the treatment of patients with non–small cell lung cancer harboring EGFR mutations, across all approved indications for amivantamab-vmjw (Rybrevant).

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-subcutaneous-amivantamab-for-egfr-nsclc

Small Cell Lung Cancer

Lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza)

Approval type: Regular

Month: October

Indication: For the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-lurbinectedin-plus-atezolizumab-as-first-line-maintenance-therapy-for-es-sclc

Tarlatamab-dlle (Imdelltra)

Approval type: Regular

Month: November

Indication: For the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or following platinum-based chemotherapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-grants-full-approval-to-tarlatamab-for-extensive-stage-small-cell-lung-cancer

Breast Cancer

Datopotamab deruxtecan-dlnk (Dato-DXd; Datroway)

Approval type: Regular

Month: January

Indication: For the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-datopotamab-deruxtecan-for-unresectable-or-metastatic-hr-her2-negative-breast-cancer

“With its differential AE [adverse effect] profile, Dato-DXd gives providers the flexibility to choose the right therapy for each patient. [I’m looking forward to] seeing more data [with this agent as they] emerge.” —Aditya Bardia, MD, MPH, FASCO, UCLA Jonsson Comprehensive Cancer Center

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu)

Month: January

Approval type: Regular

Indication: For the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low (immunohistochemistry [IHC] 1+ or 2+/in situ hybridization negative) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on 1 or more endocrine therapies in the metastatic setting.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-trastuzumab-deruxtecan-for-pretreated-her2-low-and--ultralow-metastatic-breast-cancer

Imlunestrant (Inluriyo)

Month: September

Approval type: Regular

Indication: For the treatment of adult patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations whose disease has progressed following 1 or more prior lines of endocrine therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-imlunestrant-for-er-her2-negative-esr1-mutated-metastatic-breast-cancer

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab (Perjeta)

Approval type: Regular

Month: December

Indication: For use as frontline treatment in adult patients with unresectable or metastatic HER2-positive (immunohistochemistry 3+ or in situ hybridization–positive) breast cancer, as determined by an FDA-approved test.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-t-dxd-plus-pertuzumab-for-her2-breast-cancer

Ovarian Cancer

Avutometinib plus defactinib (Avmapki Fakzynja Co-Pack)

Month: May

Approval type: Accelerated

Indication: For adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have previously received systemic therapy.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-avutometinib-plus-defactinib-for-kras-mutated-recurrent-low-grade-serous-ovarian-cancer

Solid Tumors

Vimseltinib (Romvimza)

Month: February

Approval type: Regular

Indication: For the treatment of patients with symptomatic tenosynovial giant cell tumor (TGCT) for whom surgical resection would potentially cause worsening functional limitation or severe morbidity.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-vimseltinib-for-tenosynovial-giant-cell-tumor

“[Vimseltinib] is another effective agent for the multidisciplinary team to use in treating patients with diffuse TGCT. There is proven efficacy, and the tolerability is terrific. [Rates of] transaminitis and [other] liver problems are diminished with this new drug.”

—R. Lor Randall, MD, FACS, University of California Davis Comprehensive Cancer Center

Larotrectinib (Vitrakvi)

Month: April

Approval type: Regular

Indication: For the treatment of adult and pediatric patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation, who have metastatic disease, or in whom surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or have progressed following treatment.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-larotrectinib-for-ntrk-positive-solid-tumors

“With next-generation sequencing being widely available to patients in the community and to community physicians, it’s absolutely worth testing your patients. If you identify a patient with an NTRK fusion, it’s like a lottery ticket for those with metastatic disease.” —David S. Hong, MD, The University of Texas MD Anderson Cancer Center

Penpulimab-kcqx plus cisplatin or carboplatin

Month: April

Approval type: Regular

Indication: For the first-line treatment of adult patients with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma (NPC), and as a single agent for adult patients with metastatic nonkeratinizing NPC with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-penpulimab-for-non-keratinizing-nasopharyngeal-carcinoma

“[Currently,] the only other drug approved by the FDA is toripalimab-tpzi [Loqtorzi], based on the phase 3 JUPITER-02 study [NCT03581786].” —Aditya Shreenivas, MD, MS, City of Hope

Pembrolizumab (Keytruda)

Month: April

Approval type: Regular

Indication: As a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent, for adult patients with resectable, locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of at least 1, as determined by an FDA-approved test.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-perioperative-pembrolizumab-for-resectable-locally-advanced-hnscc

Pembrolizumab and berahyaluronidase alfa-pmph (subcutaneous pembrolizumab; Keytruda Qlex)

Month: September

Approval type: Regular

Indication: For subcutaneous injection use in patients 12 years and older with solid tumor indications approved for the intravenous formulation of pembrolizumab.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-subcutaneous-pembrolizumab-for-solid-tumors

Skin Cancer

Mirdametinib (Gomekli)

Approval type: Regular

Month: October

Indication: For the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-adjuvant-cemiplimab-for-cutaneous-squamous-cell-carcinoma

“What’s most important is that this approval provides clinicians and patients with options, especially in cases where recurrence risk is unexpectedly high after surgery and radiation. We now have strong data to guide decision-making when that clinical situation arises.” —Vishal A. Patel, MD, FAAD, FACMS, George Washington (GW) University School of Medicine and Health Sciences and GW Cancer Center

Additional Approvals

Mirdametinib (Gomekli)

Approval type: Regular

Month: February

Indication: For patients 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-mirdametinib-for-nf1-associated-plexiform-neurofibromas

Selumetinib (Koselugo)

Approval type: Regular

Month: November

Indication: For the treatment of adult patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-selumetinib-for-adult-nf1-associated-plexiform-neurofibromas

Belzutifan (Welireg)

Approval type: Regular

Month: May

Indication: For the treatment of patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

TO READ MORE, VISIT:https://www.onclive.com/view/fda-approves-belzutifan-for-advanced-pheochromocytoma-and-paraganglioma

Dordaviprone (Modeyso)

Month: May

Approval type: Accelerated

Indication: For the treatment of patients 1 year and older with diffuse midline glioma harboring an H3K27M mutation who have progressive disease following prior therapy.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-dordaviprone-for-diffuse-midline-glioma

Rilzabrutinib (Wayrilz)

Approval type: Regular

Month: September

Indication: For the treatment of adult patients with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

TO READ MORE, VISIT: https://www.onclive.com/view/rilzabrutinib-nets-approval-in-pretreated-immune-thrombocytopenia

New Formulation/Biosimilar Approvals

Tablet formulation of zanubrutinib (Brukinsa)

Month: June

Indication: For use in all 5 approved indications of the capsule formulation.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-tablet-formulation-of-zanubrutinib-for-b-cell-malignancies

Gallium Ga 68 gozetotide injection (Illuccix)

Month: June

Indication: To include its use in PET imaging patient selection for radioligand therapy in the pretaxane setting in patients with metastatic castration-resistant prostate cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-illuccix-gallium-ga-68-gozetotide-injection-for-pre-taxane-radioligand-therapy-in-mcrpc

Ibrutinib (Imbruvica)generic tablet formulation

Month: July

Indication: For the treatment of select patients with B-cell malignancies. The approval includes tablets at dosages of 140 mg, 280 mg, and 420 mg, mirroring the approved tablets for the reference medication.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-generic-ibrutinib-tablets-for-b-cell-malignancies

Intravenous formulation of tocilizumab-anoh (Avtozma)

Month: August

Indication: For the treatment of patients 2 years and older with chimeric antigen receptor T-cell therapy–induced severe or life-threatening cytokine release syndrome.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-tocilizumab-biosimilar-for-car-t-cell-therapy-induced-crs

Subcutaneous depot formulation of leuprolide mesylate (Camcevi ETM)

Month: August

Indication: For the palliative treatment of adult patients with advanced prostate cancer.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-3-month-version-of-leuprolide-mesylate-for-advanced-prostate-cancer

Denosumab-nxxp (Bildyos and Bilprevda)

Month: September

Indication: Biosimilars for use in all indications of the reference product denosumab-nxxp, referencing Prolia and Xgeva, respectively.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-new-denosumab-biosimilars-for-osteoporosis-and-cancer-related-bone-disease

Subcutaneous denosumab-kyqq (Bosaya)and denosumab-kyqq (Aukelso)

Month: September

Indication: Biosimilars for reference product denosumab (Prolia and Xgeva, respectively). The FDA also granted a provisional interchangeability designation for Bosaya and Aukelso.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-2-denosumab-biosimilars-in-high-fracture-risk-populations-including-in-breast-and-prostate-cancer

Denosumab-qbde (Enoby) and denosumab-qbde (Xtrenbo)

Month: September

Indication: Biosimilars for use in all indications of the reference products for denosumab.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-2-biosimilars-for-osteoporosis-and-cancer-related-bone-disease

Generic dasatinib

Month: October

Indication: All indications of the reference drug dasatinib (Sprycel).

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-generic-dasatinib-tablets-for-cml-all

Denosumab-desu (Enoby) and denosumab-qbde (Xtrenbo)

Month: October

Indication: In all the same indications as the biosimilars referencing denosumab, Prolia and Xgeva, respectively.

TO READ MORE, VISIT: https://www.onclive.com/view/fda-approves-osvyrti-and-jubereq-in-high-fracture-risk-populations-including-in-breast-and-prostate-cancer