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. 

Scientist
FDA Presses Green Light For Vitrakvi • Source: Shutterstock

In a momentous move for precision medicine, the FDA has granted accelerated approval to Loxo Oncology Inc. and Bayer AG's cancer treatment Vitrakvi (larotrectinib) based on a common biomarker rather than the location in the body where the tumor originated.

Vitrakvi has got the thumbs-up for the treatment of both adult and children with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or have progressed following therapy

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