Drugs

Panel to Review FDA Concerns on Puma Breast Cancer Drug

A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over “uncertainty in the magnitude of treatment effect due to unplanned” and multiple amendments to the clinical trial protocol involving Puma Biotech’s Nerlynx (neratinib) and its proposed indication for the extended adjuvant treatment of adult patients with early stage ERBB2-positive breast cancer who have received prior adjuvant trastuzumab-based therapy. The agency’s concerns were so great it advised the company not to file an NDA based on its current data, according to a briefing document released in advance of the meeting.

The briefing document notes that effects of major amendments included:

Study population enriched with high-risk patients
Study follow-up time shortened from five years to two years; analysis changed from event-driven to time-driven
Re-consent process introduced to extend follow-up to five years post randomization

However, the document did offer a glimmer of hope in its analysis on the company’s data. “Despite the unplanned amendments and potential uncertainty introduced with respect to the magnitude of neratinib effect, based on the sensitivity analyses conducted, the results appear to be generally similar to the primary analysis results, supporting an effect of neratinib,” FDA says. But the tolerability of neratinib remains a concern, the agency says, “given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea.” In Study 3004, nearly all patients experienced some grade of diarrhea and 40% of patients experienced Grade 3 diarrhea, the agency says, adding that “(r)esults from the ongoing Phase 2 Study 6201 suggest that antidiarrheal prophylaxis decreases the incidence and severity of diarrhea.”

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