FDA Nod For Loxo/Bayer Tissue Agnostic Drug Marks Paradigm Shift In Cancer
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.
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New approaches in study design and methodology, including master protocol trials, are being adopted by biopharma.
Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.
Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.