TRK fusion cancer occurs in a wide range of tumour types with varying frequency, in adults and children1. It is diagnosed by the identification of NTRK genetic fusions with specific tests. 2 patients eligible for Vitrakvi treatment must be selected on the basis of a NTRK genetic fusion in their tumor.2 Bayers Vitrakvi treats cancers throughout the body of patients with an NTRK gene. Fusion. From NICE`s point of view, there is no standard treatment in this class, so the current treatment is based on where the cancer starts. The Food and Drug Administration`s accelerated approval of Loxo Oncology and Vitrakvi (Larotrectinib) last week was widely announced, the second time the Agency has given a drug a tissue-based biomarker label. But it is also an important step in the development of value-based health care. This makes patient research a challenge, but it is also part of Vitrakvis` admission into value-based care. Like ALK, NTRK is not just any genetic mutation, but a so-called oncogenic conductor, which means it plays a key role in the growth of cancers. This means that, like Xalkori, the drug has a good chance of working in patients who have a NTRK fusion. The acceleration of marketing authorization last week was based on a small sample size – 55 adult and pediatric patients in 3 studies involving a large number of advanced solid tumors – but with a total response rate of 75%, including 22% complete remission. And the responses were long-lasting, with 73% of the 41 responses lasting six months or more. After all, the whole meaning of value-based care is that payers cover treatments that are likely to work, instead of paying without a plan for treatments that don`t.
A Bayer spokesperson told me that the company was working to ensure that payers were informed of the data and the need to confirm the presence of NTRK mergers. “As we said when the acquisition was announced, most of the value we see at Loxo comes from the potential of LOXO-292,” a Lilly spokesperson said in an email. An expert I interviewed for Vitrakvi`s story, Dr. Vivek Subbiah of MD Anderson Cancer Center at the University of Texas at Houston, advocated for the examination of all cancer patients. While it would be expensive in itself, it would save money in the long run by helping many patients do what Olson has. As more biomarker-based drugs, such as Vitrakvi, are brought to market, this may become a necessity, but it will also play a key role in promoting value-based care in oncology. “For Lilly, the value of the acquisition did not depend on Bayer`s decision regarding the co-promotion agreement for TRK inhibitors.