Oncology Fellows Presents a New Drug Cheat Sheet for Fellows

In this special spread, Oncology Fellows spotlights some of the most notable new drugs and combination regimens that earned FDA approval in 2025. This resource was designed to put the most important safety and efficacy data for these treatment approaches at your fingertips for quick reference, so you can feel confident using them during training and in future practice.

Lung Cancer

Telisotuzumab vedotin-tllv (Emrelis)¹

FDA approval date: May 14, 2025

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

Supporting clinical trial: Phase 2 LUMINOSITY trial (NCT03539536)

Efficacy: Patients (n = 84) achieved an overall response rate (ORR) of 35% (95% CI, 24%-46%) and a median duration of response (DOR) of 7.2 months (95% CI, 4.2-12).

Safety profile: The most common any-grade adverse effects (AEs) that occurred in at least 20% of patients included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.

Zongertinib (Hernexeos)²

FDA approval date: August 8, 2025

Indication: For adult patients with unresectable or metastatic nonsquamous NSCLC with HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

Supporting clinical trial:Phase 1 Beamion LUNG-1 study (NCT04886804)

Efficacy: Patients who previously received platinum-based chemotherapy without a HER2-directed TKI or antibody drug conjugate (ADC; n = 71) experienced an ORR of 75% (95% CI, 63%-83%) and a 6-month DOR rate of 58%. Those who had received platinum-based chemotherapy and a HER2-targeted ADC (n = 34) experienced an ORR of 44% (95% CI, 29%-61%), with a 6-month DOR rate of 27%.

Safety profile: Most treatment-related AEs (TRAEs) were grade 1 or 2; the most common TRAEs included diarrhea (51%) and rash (27%). TRAEs led to dose reductions and discontinuations in 5% and 3% of patients, respectively.

Gynecologic Cancers

Avutometinib plus defactinib (Avmapki Fakzynja Co-Pack)³

FDA approval date: May 8, 2025

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

Supporting clinical trial: Phase 2 RAMP-201 trial (NCT04625270)

Efficacy: The confirmed ORR among patients who received the doublet (n = 57) was 44% (95% CI, 31%-58%). The DOR ranged from 3.3 months to 31.1 months.

Safety profile: The most common any-grade AEs that occurred in at least 25% of patients included increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Hematologic Malignancies

Linvoseltamab-gcpt (Lynozyfic)⁴

FDA approval date: July 2, 2025

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

Supporting clinical trial: Phase 1/2 LINKER-MM1 trial (NCT03761108)

Efficacy: Patients who received at least 4 lines of therapy, including a PI, an IMiD, and anti-CD38 monoclonal antibody, (n = 80) had an ORR of 70% (95% CI, 59%-80%). The estimated 12-month DOR rate was 72% (95% CI, 54%-84%).

Safety profile: The agent has a boxed warning for life- threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).

Lisocabtagene maraleucel (liso-cel; Breyanzi)⁵

FDA approval date: December 4, 2025

Indication: For adults with relapsed/refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.

Supporting clinical trial: Phase 2 TRANSCEND FL trial (NCT04245839)

Efficacy: Those in the intention-to-treat population of the MZL cohort achieved an ORR of 84.4% (95% CI, 74.4%-91.7%), a complete response rate of 55.8% (95% CI, 44.1%-67.2%), and a median DOR that was not reached (NR; 95% CI, 25.59 to NR).

Safety profile: Liso-cel carries warnings for CRS, neurologic toxicities, hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and immune effector-cell-associated hemophagocytic lymphohistiocytosis-like syndrome.

Breast Cancer

Datopotamab deruxtecan-dlnk (Dato-DXd; Datroway)⁶

FDA approval date: January 17, 2025

Indication: For adults with unresectable or metastatic, hormone receptor–positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization [ISH]–negative) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Supporting clinical trial: Phase 3 TROPION-Breast01 trial (NCT05104866)

Efficacy: Patients who received Dato-DXd (n = 365) achieved a median progression-free survival (PFS) of 6.9 months (95% CI, 5.7-7.4) and a median overall survival (OS) of 18.6 months (95% CI, 17.3-20.1).

Safety profile: The most common any-grade AEs that occurred in at least 20% of patients included stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, and vomiting.

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab (Perjeta)⁷

FDA approval date: December 15, 2025.

Indication: For first-line use in adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH–positive) breast cancer, as determined by an FDA-approved test.

Supporting clinical trial: Phase 3 DESTINY-Breast09 trial (NCT04784715)

Efficacy: Patients who received the combination (n = 383) had a median PFS of 40.7 months (95% CI, 36.5-not estimable [NE]) and a confirmed ORR of 87% (95% CI, 83%-90%).

Safety profile: The combination carries warnings and precautions for neutropenia and left ventricular dysfunction.

Gastrointestinal Cancers

Sotorasib (Lumakras) plus panitumumab (Vectibix)⁸

FDA approval date: January 16, 2025

Indication: For adults with KRAS G12C–mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Supporting clinical trial: Phase 3 CodeBreaK 300 study (NCT05198934)

Efficacy: The median PFS was 5.6 months (95% CI, 4.2-6.3), the ORR was 26% (95% CI, 15%-40%), and the median DOR was 4.4 months (range, 1.9+ to 6+).

Safety profile: The most common any-grade AEs that occurred in at least 20% of patients included rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain.

Nivolumab (Opdivo) plus ipilimumab (Yervoy)⁹

FDA approval date: April 11, 2025

Indication: For the frontline treatment of adults with unresectable or metastatic hepatocellular carcinoma (HCC).

Supporting clinical trial:Phase 3 CheckMate 9DW trial (NCT04039607)

Efficacy: The median OS was 23.7 months (95% CI: 18.8, 29.4) and the ORR was 36.1% (95% CI: 31.0%-41.5%).

Safety profile: The most common any-grade AEs that were reported in at least 20% of patients included rash, pruritus, fatigue, and diarrhea.

Genitourinary Cancers

Gemcitabine intravesical system (Inlexzo; TAR-200)¹⁰

FDA approval date: September 9, 2025

Indication: For adults with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

Supporting clinical trial: Phase 2b SunRISe-1 trial (NCT04640623)

Efficacy: Patients (n = 83) experienced a CR rate of 82% (95% CI, 72%-90%). Most patients with a CR had a DOR of at least 12 months (51%).

Safety profile: The treatment has warnings and precautions for risk of metastatic bladder cancer with delayed cystectomy, MRI safety, and embryo-fetal toxicity.

Rucaparib (Rubraca)¹¹

FDA approval date: December 17, 2025

Indication: For adults with BRCA mutation–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor–directed therapy.

Supporting clinical trial: Phase 3 TRITON3 trial (NCT02975934)

Efficacy: Patients with BRCA-mutated disease (n = 302) had a median radiographic PFS of 11.2 months (95% CI, 9.2-13.8) and a median OS of 23.2 months (95% CI, 19.1-25.2).

Safety profile: The agent carries warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia and embryo-fetal toxicity.

References

1. FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression. FDA. May 14, 2025.Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression
2. FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations. FDA. August 8, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations
3. FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer. FDA. May 8, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low
4. FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. FDA. July 2, 2025. Accessed January 28, 2026.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma
5. FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma. FDA. December 4, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
6. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. FDA. January 17, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast
7. FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer. FDA. December 15, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive
8. FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer. FDA. January 16, 2025. Accessed January 28, 2026.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer
9. FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma. FDA. April 11, 2025. Accessed January 28, 2026.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma
10. FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer. FDA. September 9, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer
11. FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer. FDA. December 17, 2025. Accessed January 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer