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
Or
- where surgical resection is likely to result in severe morbidity
- have no satisfactory alternative treatments
Or
- 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.
https://www.forbes.com/sites/matthewherper/2018/11/26/loxo-and-bayers-amazing-drug-has-an-expensive-price/#770ebfb624d0
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