Drugs

Priority Review for Keytruda Head/Neck Cancer sBLA

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment. The submission also seeks approval for its continued adjuvant use in combination with standard-of-care radiotherapy with or without cisplatin, and then as a single agent. The agency has set a user fee review action target date of 6/23.

The submission is based on data from the Phase 3 KEYNOTE-689 trial, which showed that in patients with resectable LA-HNSCC, the Keytruda perioperative treatment regimen “demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to adjuvant radiotherapy (with or without cisplatin) alone,” Merck says. The study also showed a statistically significant improvement in the secondary endpoint of major pathological response for patients ion Keytruda compared with adjuvant radiotherapy alone, it adds. The safety profile is said to be consistent with that seen in previously reported studies, and no new safety signals were identified.

Keytruda is currently approved as monotherapy and in combination regimens for certain patients with metastatic or with unresectable, recurrent HNSCC, according to the company.

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