Jefferies analysts predict Roche's Rozlytrek could rack up $700 million in peak global sales. (Roche)
Roche’s targeted cancer drug Rozlytrek is officially cleared for U.S. launch—and in not one, but two indications.
Thursday, the FDA green-lighted the medication to treat adults with ROS1-positive non-small cell lung cancer. Separately, it approved the product in both adults and children aged 12 and older with tough-to-treat NTRK fusion-positive tumors.
For cancer powerhouse Roche, it’s the first FDA go-ahead that isn’t tied to a tumor’s particular location in the body: NTRK gene fusions have been found in a range of tumor types, including breast, colorectal, neuroendocrine, lung and thyroid cancers.
The company was also quick to point out that Rozlytrek has delivered responses in cancer that has spread to the brain. That fact is particularly important in ROS1-positive NSCLC patients, up to 40% of whom have tumors that have done exactly that.
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The OKs aren’t the first for Rozlytrek, which made its global debut with an NTRK approval from Japan’s Ministry of Health, Labour and Welfare back in June. It’s awaiting a ROS1 nod from the country as well, along with European regulators’ blessings in both indications.
Those approvals will go a long way toward helping Rozlytrek hit the $700 million in peak global sales Jefferies analysts have predicted for the drug. But NTRK sales won’t come easy: Rozlytrek will go up against Bayer’s Vitrakvi, another tumor-agnostic drug that grabbed its own U.S. approval last November.
While Bernstein analyst Wimal Kapadia has forecast peak sales of €900 million for Vitrakvi, it’s tough to write off any oncology med with Roche behind it. “Any decent cancer drug in Roches hands becomes interesting," Kapadia wrote in a recent note to clients.
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A companion diagnostic would certainly help Rozlytrek in the sales department, considering that biomarker testing for ROS1 in NSCLC and for NTRK fusions is the only way to identify eligible patients. Right now, though, an FDA-approved companion isn’t available, though Foundation Medicine plans to submit one to regulators.
