Kristi Rosa

The European Commission has approved enfortumab vedotin for use as a single agent in adult patients with locally advanced or metastatic urothelial cancer who have received prior platinum-containing therapy and a PD-1/L1 inhibitor.

The FDA has cleared an investigational new drug application for 177Lu-rhPSMA-10.1 as a potential therapeutic option for patients with metastatic castration-resistant prostate cancer.

The FDA has placed a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma study investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

The FDA has lifted a partial clinical hold that had been placed on studies examining magrolimab in combination with azacitidine following a review of comprehensive safety data collected from each trial.

Zanubrutinib demonstrated superiority over ibrutinib in terms of overall response rate per independent review committee assessment in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The dual immunotherapy combination of nivolumab and ipilimumab elicited encouraging and durable responses with acceptable safety in patients with advanced or metastatic tumor mutational burden–high solid tumors that were refractory to standard therapies, meeting the primary end points of the phase 2 CheckMate-848 trial.

Zanubrutinib monotherapy continues to demonstrate durable responses with an acceptable toxicity profile in patients with relapsed or refractory mantle cell lymphoma.

The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.

The combination of the oncolytic vaccine vusolimogene oderparepvec and nivolumab continued to drive encouraging responses with acceptable tolerability in patients with melanoma and other skin cancers.

Marketing authorization applications seeking the approval of tislelizumab in patients with advanced or metastatic esophageal squamous cell carcinoma following previous systemic chemotherapy and in select patients with non–small cell lung cancer have been submitted to the European Medicines Agency.

The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application seeking the approval of lifileucel in the treatment of patients with metastatic melanoma.

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.

The European Commission has granted marketing authorization to the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for use in adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic treatment.

The European Commission has approved nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher on tumor cells.

The European Commission has approved nivolumab for use in the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma and a PD-L1 expression of 1% or higher on tumor cells, who are at a high risk of recurrence following radical resection.

The FDA has placed a partial clinical hold on the phase 1/2a TakeAim Leukemia trial, which is evaluating emavusertib as a single agent and in combination with azacitidine or venetoclax in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.

A Type II variation application seeking the approval of a new indication for ibrutinib plus bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma who are not candidates for autologous stem cell transplant has been submitted to the European Medicines Agency.

The FDA has granted a fast track designation to the multigenic autologous CAR T-cell therapy PRGN-3006 for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia.

Selpercatinib continued to provide clinically meaningful benefit to patients with metastatic RET fusion–positive non–small cell lung cancer.

The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

A biologics license application seeking the approval of 131I-omburtamab in the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been resubmitted to the FDA.

The addition of relacorilant to nab-paclitaxel improved overall survival compared with nab-paclitaxel alone in patients with recurrent, platinum-resistant ovarian cancer.

The combination of eftilagimod alpha and pembrolizumab was found to produce an encouraging early overall survival rate of 73% at the 6-month landmark when used as second-line treatment in patients with PD-1/PD-L1–refractory, metastatic non–small cell lung cancer, according to data from part B of the phase 2 TACTI-002 trial.

Rucaparib significantly improved investigator-assessed progression-free survival over placebo when used as maintenance treatment in newly diagnosed patients with advanced ovarian cancer following successful first-line treatment with platinum-based chemotherapy, according to top-line findings from the monotherapy arm of the phase 3 ATHENA trial.

The addition of the anti-TIGIT immunotherapy tiragolumab to atezolizumab plus carboplatin/etoposide failed to significantly improve progression-free survival over atezolizumab/chemotherapy alone when used in the frontline treatment of patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase 3 SKYSCRAPER-02 trial.

The FDA has granted priority review to a new drug application seeking the approval of futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.

The FDA has granted an orphan drug designation to Veyonda, a novel proprietary formulation of idronoxil, for use as a potential therapeutic option in patients with soft tissue sarcoma.

The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.

A biologics license application has been submitted to the FDA for the use of mirvetuximab soravtansine monotherapy in patients with platinum-resistant ovarian cancer and high folate receptor–alpha expression who have received 1 to 3 prior systemic treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.