After three weeks of brutal combat, Richard Pazdur decided that he has had enough.
Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”
FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.
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.
