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.
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.
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.
Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.
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.
Rick Pazdur’s appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) comes at exactly the right moment, both for the agency and for the patients it serves.
Top FDA officials said the agency is in the process of removing the black box safety warnings from all forms of menopausal hormone therapy, including creams, pills, and other treatments prescribed to ease the symptoms of menopause and perimenopause.
With the recent FDA approval of daratumumab for high-risk smoldering multiple myeloma, the moment is ripe to revisit the evolution of our understanding of smoldering multiple myeloma. This development not only underscores the growing recognition of early intervention but also invites a broader reflection on the biological insights and therapeutic strategies that have shaped—and continue to shape—this transitional disease state.
FDA has granted full approval of Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a devastating blood cancer with limited treatment options.
