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US FDA Outlines Streamlined Development Path For Targeted Therapies

 
• By Derrick Gingery

But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.

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The US FDA has laid out a more definitive pathway for molecularly-targeted drugs seeking indications in multiple patient subsets, but still left open the possibility that additional clinical evidence could be ordered or indications adjusted later should contrary evidence arise.

The new draft guidance outlining development standards for targeted therapies in low-frequency molecular subsets of a disease allows sponsors...

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• By Sue Sutter

The agency identified deficiencies in efficacy evidence intended to support results from a single adequate and well-controlled trial for orphan applications, including weaknesses in animal data and insufficient quantity and quality of biomarker data.

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• By Sue Sutter

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US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
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Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
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