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Gleevec Extends Post-Surgery GIST Survival Significantly; Wins Full Adjuvant Approval

 
• By Shirley Haley

Patients who took Novartis’ Gleevec for three years after surgery to remove gastrointestinal stromal tumors had a 54% reduction in risk of recurrence and a 55% reduction in risk of death compared to patients who took it for only one year.

Novartis AG received full FDA approval to expand labeling for its oncology blockbuster Gleevec (imatinib) to include three years of treatment following surgery to remove KIT-positive gastrointestinal stromal tumors based on final clinical data showing a survival advantage with the extended regimen, the company announced Jan. 31.

The approval comes from an open-label Phase III trial comparing 12 months of treatment with imatinib to 36 months of...

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US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 
• By Bridget Silverman

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

More from North America

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.