Vitrakvi Granted FDA
November 27, 2018 – The U.S. FDA has approved Vitrakvi® (larotrectinib), manufactured by Bayer and Loxo Oncology, to treat certain adult and pediatric patients who have solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion and without a known acquired resistance mutation. Vitrakvi is the first oral tropomyosin receptor kinase (TRK) inhibitor to receive FDA approval, and the first FDA-approved drug to receive a tissue-agnostic indication.
Tissue-agnostic oncology targets cancer based on biomarkers rather than the disease’s site of origin (such as the liver or colon). Vitrakvi targets a biomarker, NTRK gene fusion, found across multiple types of tumors. When NTRK genes fuse abnormally with other genes, they send signals that drive tumor growth. Vitrakvi works to block these signals. In clinical trials, it was found to be effective across multiple types of tumors, including thyroid, lung, breast, colon, melanoma, soft tissue sarcoma, and infantile fibrosarcoma. The overall response rate in trials was 75%, with a complete response rate of 22%.
Under the FDA-approved indication, Vitrakvi can be used to treat patients who have metastatic tumors, or tumors that cannot be removed surgically without a likely outcome of severe morbidity. Patients should also have no satisfactory alternative treatments available, or disease that has progressed following treatment. Recommended dosing is 100mg orally twice daily in adults and in pediatric patients whose body surface area is at least 1m2. For pediatric patients whose body surface area is less than 1m2, the recommend dose is 100mg/m2 orally twice daily. The product is available in 25mg and 100mg capsules, as well as a 20mg/mL oral solution.
Bayer launched Vitrakvi immediately upon approval at a wholesale acquisition cost (WAC) of $32,800 for a 30-day supply 100mg capsules. The Vitrakvi Commitment Program™ will refund payers, patients, and third-party organizations paying on behalf of patients in the event an eligible patient does not experience clinical benefit within 90 days of treatment initiation.