FDA Grants Complete Approval To Bayer's Drug For Certain Type Cancer With Mutation

The U.S. Food And Drug Administration (FDA) granted full approval to Bayer AG’s BAYRY Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Vitrakvi has demonstrated clinically meaningful and durable responses across various NTRK fusion-positive solid tumors. FDA first granted Vitrakvi accelerated approval in November 2018.

The approval is based on data from three multicenter, open-label, single-arm clinical trials.

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The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).

Pooled efficacy results showed an ORR of 60% with a complete response (CR) rate of 24% and a partial response (PR) rate of 36%.

5% of patients with complete response were pathological complete response.

Patients undergoing a surgical resection whose post-operative pathologic assessment showed no viable tumor cells and negative margins were pathological complete responders provided that no other sites of disease were present. The median DOR was 43.3 months.

Price Action: BAYRY stock closed higher by 2.74% to $5.63 on Thursday.

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