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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In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.
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.