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Accelerated Approval Roadblock: Agenus’ PD-1 Stumble Reflects Pathway’s Regulatory Risk

 
• By Sue Sutter and Bridget Silverman

Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.

Roadblock
Balstilimab's road to accelerated approval was blocked by Keytruda's conversion to regular approval in second-line cervical cancer. • Source: Alamy

Agenus Inc.’s recent BLA withdrawal for the PD-1 inhibitor balstilimab in second-line cervical cancer has shined a light on rare instances in which a drug seeking accelerated approval is blocked by a competing product’s conversion from accelerated to regular approval.

However, the Agenus experience offers some lessons for sponsors more broadly by highlighting the regulatory risk that comes with pinning...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

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US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.