Drugs

Bayer sNDA for Hyrnuo Granted Priority Review

FDA has granted Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The filing seeks approval for sevabertinib in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry HER2 tyrosine kinase domain activating mutations.

The submission is based on preliminary results from cohort F of the ongoing Phase 1-2 OHO-01 trial, which is evaluating the efficacy and safety of sevabertinib in previously untreated patients with advanced HER2-mutant NSCLC. “Patients with HER2-mutant NSCLC currently have limited treatment options, and there is an urgent need for more effective and better-tolerated therapies that can be used early in the disease course to help improve survival outcomes,” a Bayer release said.

Hyrnuo received an accelerated FDA approval in November for previously treated patients with advanced HER2-mutant NSCLC based on tumor response and duration-of-response data from the SOHO-01 study.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for more than 85% of cases. HER2 mutations occur in roughly 2% to 4% of advanced NSCLC patients, according to Bayer.

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