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FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint

 
• By Michael Cipriano

Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.

The US FDA has shown a vote of confidence in using minimal residual disease (MRD) as a response endpoint with the accelerated approval of a supplemental indication for Amgen's Blincyto (blinatumomab) to treat adults and children with MRD-positive acute lymphoblastic leukemia (ALL).

It is the first FDA-approved treatment for MRD-positive ALL, which involves the presence of a small amount of detectible cancer cells remaining after treatment, and can be seen as an endorsement of this surrogate measure, which is being explored across other hematologic malignancies. Also see "Minimal Residual Disease 'Coming Soon' As An Approval Endpoint, Celgene Says" - Pink Sheet, 13 December, 2017

More from Approvals

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.