Biologics

Rybrevant Faspro sBLA Gets Priority Review for Head & Neck Cancer

FDA has accepted for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma. If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, according to the company.

“Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumor types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways,” a company release says.

J&J says subcutaneous amivantamab was designed to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) while engaging the immune system. “Overexpression of EGFR and MET receptors is seen in 80 to 90% of head and neck squamous cell carcinoma tumors and has been implicated in tumor progression and treatment resistance, it adds.

The priority review decision was based on data from the pivotal Phase 1b/2 OrigAMI-4 study, which showed that 42% of patients responded to treatment with monotherapy subcutaneous amivantamab, with more than one-third of responders achieving a complete response, according to the company.

The therapy is currently approved in the U.S. and more than 40 other countries as a subcutaneous treatment for non-small cell lung cancer and continues to be evaluated in additional tumor types.

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