Drugs

Cogent Bio Plans NDA for Bezuclastinib

Cogent Biosciences says FDA has agreed to accept the company’s planned NDA for cancer drug bezuclastinib under the agency’s Real-Time Oncology Review program, based on positive late-stage trial results in patients with gastrointestinal stromal tumors (GIST). The company will seek approval for the therapy and its use in combination with sunitinib (Pfizer's Sutent) for patients with GIST whose disease has progressed after treatment with imatinib (Novartis' Gleevic/Glivic and generics). Cogent expects to initiate the rolling submission process immediately, with completion of the full NDA targeted for April.

The NDA will be based on results from the Phase 3 PEAK trial, which the company says is the first study in this patient population to demonstrate a statistically significant benefit over an active comparator. In the trial, bezuclastinib combined with sunitinib achieved a median progression-free survival of 16.5 months, compared with 9.2 months for sunitinib alone, as assessed by a blinded independent central review.

The combination reduced the risk of disease progression or death by 50% versus the current standard of care, the company says. The overall response rate was 46% among patients receiving the bezuclastinib regimen, compared with 26% for patients treated with sunitinib monotherapy. Overall survival data were not yet mature at the time of the analysis.

FDA’s Real-Time Oncology Review program allows companies to submit components of an NDA in advance of a complete filing, enabling regulators to begin evaluating clinical data earlier in an effort to speed access to promising cancer therapies.

The company also plans to initiate a Phase 2 study in mid-2026 to evaluate the bezuclastinib combination as a potential first-line treatment for GIST patients with exon 9 mutations who are naïve to, or recently started on, imatinib.

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