FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.
FDA has granted 510(k) clearance for use of the Vanquish System for prostate tissue ablation. FDA clearance was supported by positive 12-month follow-up data on the first 110 patients enrolled in the company’s ongoing VAPOR 2 clinical study.
FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.
Rick Pazdur, MD, the newly appointed director for the Center for Drug Evaluation and Research at the FDA, has been described as “greyhound thin” as a result of his dedication to cycling and lifting weights in the gym each day and, for a long time, a vegetarian diet. I first met him when he was the director of the Office of Oncology Drug Products (ODP) within CDER, in 2009.
FDA Commissioner Marty Makary and Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, jointly published a letter in The New England Journal of Medicine spelling out the rationale for FDA’s new “plausible mechanism pathway,” aimed at getting bespoke therapies to market without the need for a randomized controlled trial.
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.
