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Roche's targeted anti-cancer drug, Rozlytrek, is officially authorized to be launched in the United States – not by one, but by two indications.
On Thursday, the FDA announced its intention to treat adults with non-small cell lung cancer ROS1 positive. Separately, he approved the product in adults and children aged 12 years and older with NTRK hard-to-treat tumors.
Roche announced that the new drug would cost adults $ 17,050 a month, a spokeswoman said, adding that it offers patient access programs that include support for medical expenses and medication. free for people meeting certain eligibility criteria.
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This sticker is more or less "compatible with monthly prices in oncology", but it is well below the $ 32,800 a month billed by Bayer for its competing drug NTRK, Vitrakvi, said Umer Raffat, ESI Analyst at Evercore, titled "The price war in cancer?"
The list price of Rozlytrek is "almost 50% off," he said, adding that "it will be a competitive dynamic very interesting to follow in the coming weeks". Bayer has its own pair of access programs, one of which reimburses the payment when patients do not respond to the drug within 90 days.
For the Roche Cancer Center, this is the first FDA test that is not linked to a particular tumor in the body: NTRK gene fusions have been found in several types of tumors, including breast cancer, colorectal , neuroendocrine, lung and thyroid.
The company was quick to point out that Rozlytrek had provided answers to cancer that had spread to the brain. This fact is particularly important in patients with NSCLC-positive NSCLC, up to 40% of whom have tumors causing exactly that.
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The OKs are not the first for Rozlytrek, who made his world debut with the NTRK approval from the Japanese Ministry of Health, Labor and Welfare in June. He also waits for a nod from the country, as well as the blessings of European regulators in both indications.
These approvals will go a long way toward helping Rozlytrek reach the $ 700 million global sales summit that Jefferies analysts have predicted for the drug. But sales of NTRK will not be easy: Rozlytrek will face Vitrakvi, another agnostic drug for tumors that was approved by the United States last November.
While Bernstein analyst Wimal Kapadia is predicting record sales of 900 million euros for Vitrakvi, it is difficult to cancel any oncology treatment with Roche. "Any decent anticancer drug in Roche's hands becomes interesting," Kapadia wrote in a recent note to clients.
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A companion diagnosis would certainly help Rozlytrek in the sales department, as the biomarker test for ROS1 in NSCLC and for NTRK fusions is the only way to identify eligible patients. For the moment, however, an FDA-approved companion is not available, although Foundation Medicine plans to submit it to regulators.
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