FDA nod for oncology drug that targets a key genetic driver of cancer

The US Food and Drug Administration yesterday approved Vitrakvi (larotrectinib), the first ever oral TRK inhibitor, for solid tumors.

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.

The FDA granted the approval of Vitrakvi to Loxo Oncology (Nasdaq: LOXO). The drug is the subject of a development and commercialization deal with German pharma major Bayer (BAYN: DE) that could earn Loxo as much as $1.55 billion, of which $400 million was paid up front.