Drugs

Daiichi Sankyo, AstraZeneca ‘Breakthrough’ for Enhertu

FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. The designation was based on results from the DESTINY-Gastric01 study that demonstrated clinically meaningful and statistically significant results, including objective response and survival increases compared to a physician’s chemotherapy choice, according to the companies. In the trial, the therapy’s overall safety and tolerability profile was reported to be consistent with that seen in a Phase 1 trial in which the most common adverse events were hematologic and gastrointestinal including neutrophil count decrease, anemia, nausea and decreased appetite. Enhertu recently received accelerated approval in the U.S. for treating adult patients with unresectable or metastatic HER2 positive metastatic breast cancer who have received two or more prior anti-HER2 based regimens.

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