Kristi Rosa

The FDA has approved avapritinib (Ayvakit) for the treatment of adults with indolent systemic mastocytosis.

The combination of GEN-002 and avelumab elicited responses in patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from an interim analysis of an ongoing phase 2 trial.

The FDA has approved the first T-cell–engaging bispecific antibody, epcoritamab-bysp (Epkinly), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.

Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.

Capivasertib plus fulvestrant provided a clinically meaningful improvement in progression-free survival over fulvestrant alone in patients with hormone receptor–positive advanced breast cancer, including those who previously received a CDK4/6 inhibitor, chemotherapy in the advanced setting, or had baseline liver metastases.

Enrollment to the phase 3 MANIFEST-2 trial, which is examining the safety and efficacy of pelabresib plus ruxolitinib vs ruxolitinib alone in patients with JAK inhibitor–naïve myelofibrosis, has completed and topline findings are anticipated by the end of 2023.

The phase 3 MATTERHORN trial examining roxadustat as an anemia treatment in patients with transfusion-dependent, lower-risk myelodysplastic syndrome did not meet its primary end point.

The gamma-delta T-cell therapies INB-400 and INB-410 have received orphan drug designations from the FDA for use as potential therapeutic options in patients with newly diagnosed glioblastoma.

Treatment with the combination of IMX-110 and tislelizumab resulted in 100% tumor shrinkage at 2 months in 2 of 2 evaluable patients with advanced metastatic colorectal cancer who received the regimen at the lowest dose level examined in the dose-escalation portion of the ongoing phase 1b/2a IMMINENT-01 trial

Lisocabtagene maraleucel elicited statistically significant and clinically meaningful responses in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma, meeting the primary end point of the phase 2 TRANSCEND FL and phase 1 TRANSCEND NHL 001 trials, respectively.

The FDA has granted full approval to cemiplimab-rwlc for the treatment of patients with metastatic basal cell carcinoma who previously received a hedgehog inhibitor (HHI) or for whom a HHI is not appropriate.

The FDA has approved xT CDx, a 648-gene next-generation sequencing assay for solid tumor profiling, and companion diagnostic for patients with colorectal cancer.

The addition of olaparib to abiraterone acetate resulted in numerically higher prostate-specific antigen response rates and prolonged time to PSA progression vs abiraterone alone when used in the frontline treatment of patients with metastatic castration-resistant prostate cancer.

The combination of toripalimab and axitinib improved progression-free survival over single-agent sunitinib when used as first-line treatment in patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of glofitamab for fixed-duration use in adult patients with relapsed or refractory diffuse large B-cell lymphoma following 2 or more lines of systemic therapy.

The FDA has placed a partial clinical hold on the phase 1 trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of FHD-609 in patients with advanced synovial sarcoma and SMARCB1-deleted tumors.

The combination of darovasertib and crizotinib demonstrated clinical activity and an acceptable safety profile when utilized in first- and any-line patients with metastatic uveal melanoma.

The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

The combination of selinexor at 60 mg and ruxolitinib induced rapid and durable spleen responses and improved symptoms at weeks 12 and 24 in patients with treatment-naïve myelofibrosis, according to updated data from the phase 1 XPORT-MF-034 trial.

The FDA has approved polatuzumab vedotin-piiq (Polivy) plus rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone for use in adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.

The FDA has accepted for priority review the supplemental new drug application seeking the approval of trifluridine/tipiracil as a single agent or in combination with bevacizumab for use in select patients with refractory, metastatic colorectal cancer.

The FDA has approved omidubicel-onlv (Omisirge) to quicken the recovery of neutrophils in the body and reduce the risk of infection in adults and pediatric patients aged 12 years and older with blood cancers who are slated to undergo umbilical cord blood transplantation after a myeloablative conditioning regimen.

Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.

The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.

The phase 3 LEAP-003 and LEAP-017 trials evaluating pembrolizumab plus lenvatinib did not meet their primary end points of overall survival in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer, respectively.

AbbVie has announced the intention to voluntarily withdraw indications for ibrutinib in patients with mantle cell lymphoma who have previously received at least 1 therapy and in those with marginal zone lymphoma who require systemic treatment and have received at least 1 prior anti–CD20-based therapy.

Single-agent liposomal irinotecan resulted in a similar median overall survival and progression-free survival to that achieved with topotecan in patients with small cell lung cancer that had progressed on or following frontline platinum-based chemotherapy.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

A new drug application seeking the approval of fruquintinib for use in the treatment of patients with refractory metastatic colorectal cancer has been submitted to the FDA.

Taletrectinib continued to demonstrate meaningful efficacy in the form of a durable objective response rate and a high intracranial ORR with acceptable tolerability in both TKI-naïve and crizotinib-pretreated patients with ROS1-positive non–small cell lung cancer.