Kristi Rosa

The FDA has accepted for priority review a biologics license application seeking the approval of a single priming dose of tremelimumab added to regular interval durvalumab in the treatment of patients with unresectable hepatocellular carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of adjuvant atezolizumab, after complete resection and platinum-based chemotherapy, in adult patients with non–small cell lung cancer with a high risk of recurrence and whose tumors express PD-L1 of 50% or higher and do not harbor EGFR mutations or ALK alterations.

The safety, tolerability, and preliminary efficacy of the irreversible, small molecule pan-FGFR inhibitor KIN-3248 is under investigation in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations, as part of the phase 1 KN-4802 trial.

The combination of tislelizumab and gemcitabine/cisplatin continued to demonstrate a greater progression-free survival benefit than chemotherapy alone when used in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer.

The China National Medical Products Administration has approved tislelizumab for use in patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression or who are intolerant to frontline standard chemotherapy.

The FDA has approved the third biosimilar for bevacizumab: bevacizumab-maly (Alymsys).

The overall response rate achieved with ruxolitinib at day 28 proved to be higher than what was achieved with best available therapy in patients with steroid-refractory acute graft-vs-host disease, irrespective of organ involvement.

The pending biologics license application and supplemental new drug application seeking the approval of the combination of ublituximab and umbralisib in adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma has been voluntarily withdrawn by TG Therapeutics, Inc.

Nektar Therapeutics and Bristol Myers Squibb have announced the decision to end the global clinical development program for the combination of bempegaldesleukin and nivolumab based on findings from preplanned analyses of 2 late-stage clinical trials.

Epcoritamab was found to produce an encouraging overall response rate in patients with relapsed or refractory large B-cell lymphoma who previously received CAR T-cell therapy.

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.