Drugs

FDA Meeting to Review Survival Data for Osteosarcoma Therapy

FDA has granted OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. OS Therapies says an interim three-year overall survival analysis is expected in early September.

The company said the meeting will focus in part on the appropriate comparator for interpreting the efficacy of OST-HER2. Specifically, FDA and the company are expected to discuss whether pooled, non-concurrent published historical control data or concurrent natural-history data generated through the company’s OST-400 study should be used.

OS Therapies said overall survival at 2.5 years remained unchanged from the two-year timepoint, which the company characterized as evidence of a sustained survival benefit.

“We are heartened that overall survival at the 2.5-year timepoint remained unchanged from the 2-year timepoint,” said Craig Eagle, OS Therapies’ chief medical advisor and a member of its board.

The company expects the upcoming FDA meeting, along with the three-year survival data, to inform pending requests for Regenerative Medicine Advanced Therapy designation and a potential rolling BLA review request.

OS Therapies says it is seeking accelerated approval of OST-HER2 by the end of 2026. The therapy has already received FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations.

OST-HER2 is described as a gene-edited, Listeria-based immunotherapy designed to stimulate an immune response against HER2-expressing cancer cells. OS Therapies reported positive results from its Phase 2b study in patients with fully resected pulmonary metastatic, including its 12-month event-free survival primary endpoint and an overall survival secondary endpoint.

Additionally, the company said FDA has accepted its letter of intent requesting a Commissioner’s National Priority Review Voucher, which would provide an expedited agency review.

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