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Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model

 
• By Michael Cipriano

FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.

The US FDA granted accelerated approval to Merck & Co. Inc.'s PD-1 inhibitor Keytruda on June 13 for a new indication in refractory primary mediastinal large B-cell lymphoma (PMBCL). But the confirmatory trial spelled out in the approval letter is more familiar: the ongoing Phase III KEYNOTE-204 trial, which is also serving as the confirmatory trial for an earlier Keytruda accelerated approval in refractory classic non-Hodgkin lymphoma.

The multiple-use confirmatory trial is becoming a more common sight in the fast-growing immuno-oncology space, and another example of the...

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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys

 
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The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

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EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.