On November 26, 2018, the FDA granted accelerated approval for Vitrakvi (larotrectinib), the first-ever neurotrophic receptor tyrosine kinase inhibitor. Vitrakvi is also the first treatment to receive a “tumor-agnostic” (not specific to an area of the body) indication at the time of initial FDA approval.
Research has shown that the NTRK genes can become fused to other genes abnormally, resulting in growth signals that support the growth of tumors. NTRK fusions are rare but occur in cancers arising in many sites of the body.
"(This) approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body," said FDA Commissioner Scott Gottlieb, M.D. "This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine.”
The full indication for Vitrakvi is intricate. It is to be used for the treatment of adult and pediatric patients with solid tumors that:
- have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
- are without a known acquired resistance mutation
- are metastatic
- where surgical resection is likely to result in severe morbidity
- have no satisfactory alternative treatments
- have progressed following treatment.
Vitrakvi demonstrated a 75% overall response rate across different types of solid tumors. These responses were durable, with 73% of responses lasting at least six months, and 39% lasting a year or more at the time results were analyzed. Examples of tumor types with an NTRK fusion that responded to Vitrakvi include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer and lung cancer.
Vitrakvi comes with a hefty price tag: $32,000 per month. Bayer will help patients with copays and will provide free drug if the patient cannot afford it. Along the lines of value-based care, Bayer will also refund money spent by insurers or government payers if there is no clinical improvement in the first 3 months of treatment.
One reason the drug is so expensive is because this condition is very rare. Bayer estimates only 2,500 to 3,000 patients in the U.S. develop cancer due to a TRK fusion each year.
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