FDA granted full approval to Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The decision to convert Imdelltra’s prior accelerated approval to a full approval is based on data from the global phase III DeLLphi-304 study.Â
FDA approved Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first approval of a biosimilar for Perjeta.
FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma.Â
FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic non-squamous 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 a prior systemic therapy.
The European Commission has approved the PD-1 inhibitor Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
The European Commission has approved a subcutaneous, or under the skin, route of administration and a new pharmaceutical form (solution for injection) of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.Â
GSK and LTZ Therapeutics, an immunotherapy-focused biotechnology company based in Redwood City, CA, will collaborate to advance the development of novel myeloid cell engagers.Â
Freenome, an early cancer detection company, and Roche announced a collaboration agreement to commercialize Freenome’s cancer screening technology in international markets.Â
Microsoft and Qure.ai announced a collaboration that will streamline deployment of Qure.ai solutions to hospitals and health systems across the U.S.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
