Pharma Will Embrace Basket And Umbrella Trials, Despite Challenges
FDA Pushing For Innovation In Trial Design
New approaches in study design and methodology, including master protocol trials, are being adopted by biopharma.
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Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.
The advent of precision medicine has prompted sponsors to experiment with complex clinical trial designs, which can involve increased operational complexity. A new EU-wide guidance has been issued on the subject to pave the way for a harmonized approach.
Vitrakvi is effective against a wide variety of cancers driven by NTRK fusion. But finding the patients who will benefit will be a challenge, given there are expected to be only around 2,500 to 3,000 new cases in the US and testing for the mutation is uncommon.