Drugs

Priority Review for Lung Cancer BLA

FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior systemic therapies. The user fee review action date is expected during the third quarter, according to the companies.

The submission is based on data from the TROPION-Lung05 Phase 2 trial and supported by data from the TROPION-Lung01 Phase 3 trial. The data demonstrated a “confirmed objective” response rate of 42.7% and a median duration of response of seven months, the companies say. The therapy’s safety profile was consistent with previous trials, and no new safety concerns were identified.

Datopotamab deruxtecan is described as a “specifically engineered” TROP2-directed DXd antibody drug conjugate.

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