Bayer announced today 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. Vitrakvi has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion cancer. For those patients with primary central nervous system (CNS) tumors and with CNS metastases, responses and a high disease control rate have been observed. It is already approved in the U.S., countries of the European Union (EU), the UK and other markets around the world.
“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. “Clinicians now have the option to replace less tailored treatment approaches with a precision oncology treatment specifically designed to treat patients with TRK fusion cancer.”
The marketing authorization of Vitrakvi follows the approval of the expanded use of FoundationOne®CDx, a comprehensive genomic profiling (CGP) test, in Japan for use as a companion diagnostic (CDx) to identify patients with TRK fusion cancer who are expected to benefit from treatment with Vitrakvi. The CDx approval is part of the global collaboration between Bayer and Foundation Medicine, Inc. (FMI), for which Chugai is the local development partner of FMI.
