Drugs

FDA Breakthrough for NRG1+ Cholangiocarcinoma Drug

FDA has granted Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use for treating cholangiocarcinoma defined by NRG1 gene fusions. The designation covers adults with advanced unresectable or metastatic NRG1+ cholangiocarcinoma, the company says, and is based on data from the Phase 2 eNRGy trial. The company says NRG1 fusions are a rare but increasingly recognized target as RNA-based next-generation sequencing proliferates in clinical practice.

Partner says a recent interim readout of the trial found:

• 37% overall response rate
• 7.4 months median duration of response
• 1.9 months median time to response
• 9.2 months median progression-free survival
• 58% clinical benefit rate (responses or durable stable disease)

PTx plans to leverage those results for a supplemental BLA filing in 2026. Zenocutuzumab-zbco (Bizengri) currently has accelerated approval for NRG1-positive non-small cell lung cancer and pancreatic cancer after prior therapy.

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