Bayer has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan. Larotrectinib is an oral TRK inhibitor that has been developed specifically to treat adults and children with locally advanced or metastatic solid tumors that have a rare genomic alteration called a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The product is already approved in several countries under the brand name Vitrakvi™, including the U.S., Brazil, Canada, and countries of the European Union (EU). Filings in other regions are underway or planned.
“With this submission, we are one step closer to providing patients and physicians in Japan with a highly selective treatment exclusively designed for adults and children with TRK fusion cancer, that has 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. “While cancers have previously been treated mainly in the body, larotrectinib was developed specifically to treat patients with TRK fusion cancer, regardless of where in the body the tumor originates. Larotrectinib represents an important advancement in the fight against this rare cancer, as it could replace costly treatment that is not targeted specifically to this cancer and does not have proven efficacy and safety in this patient population.”
The submission to the MHLW is based on clinical trial data from the Phase I trial of adult patients, Phase II NAVIGATE trial in adult and adolescent patients, and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland, and infantile fibrosarcoma.
TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.
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