Drugs

Durvalumab Regimen OK’d for Gastroesophageal Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The regimen — durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) — will be used both before and after surgery, followed by single-agent durvalumab for up to 10 additional cycles. It marks the first immunotherapy-chemotherapy combination cleared in the U.S. for this setting, an FDA release says.

FDA based the approval on data from the 948-patient MATTERHORN trial, a global, randomized, double-blind study evaluating the combination in previously untreated, resectable Stage II–IVA gastric or GEJ adenocarcinoma. Patients receiving durvalumab plus FLOT had significantly longer event-free survival than those receiving FLOT alone, the agency says. Median event-free survival had not yet been reached in the durvalumab arm, compared with 32.8 months in the control group, representing a 29% reduction in the risk of events, it adds.

Additionally, FDA says that overall survival also favored the durvalumab regimen, although medians were not reached in either arm at the time of analysis. The pathologic complete response rate more than doubled with durvalumab — 19.2% versus 7.2% on chemotherapy alone.

Imfinzi’s prescribing information carries warnings for immune-mediated adverse reactions, infusion reactions, complications following allogeneic stem-cell transplantation, and embryo-fetal toxicity.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome