Bayer’s NTRK fusion-positive tumor drug approved in Japan

Bayer has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi, for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors.

Vitrakvi is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion.

“There remains a high unmet need for new and innovative cancer treatments in Japan. The approval of Vitrakvi marks an important step towards treating TRK fusion cancer based on the oncogenic driver rather than the site or origin in the body,” said Makoto Tahara, MD., Ph.D. Chief, Department of Head and Neck Medical Oncology, National Cancer Center Hospital East.

The marketing authorization of Vitrakvi follows the approval of the expanded use of FoundationOne CDx, a comprehensive genomic profiling test, in Japan for use as a companion diagnostic to identify patients with TRK fusion cancer who are expected to benefit from treatment with Vitrakvi.

“Treatments that directly address the genomic abnormality driving tumor growth, such as Vitrakvi, can provide value to patients and physicians in Japan with the potential to significantly improve treatment outcomes regardless of tumor type or patient age,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division.

TRK fusion cancer is rare overall, affecting both children and adults and occurs in varying frequencies across various tumor typ.

Vitrakvi is approved in more than 40 countries, including the U.S., countries of the European Union (EU), the UK and other markets around the world.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer now possesses the exclusive rights to develop and commercialize larotrectinib worldwide, and also has exclusive rights to the investigational TRK inhibitor selitrectinib (BAY 2731954) which is currently in clinical development, the company said.