As cancer treatment continues a march toward increasingly targeted therapies, Roche has secured its first global approval for Rozlytrek, a med designed to fight NTRK fusion-positive tumors and one that appears on a collision course with Bayer's Vitrakvi.
Japan’s Ministry of Health, Labour and Welfare (MHLW) signed off on Roche's drug to treat patients with NTRK fusion-positive advanced recurrent solid tumors. Such tumors are hard to treat and appear in the pancreas, thyroid, salivary gland and lungs. Bayer's Vitrakvi also treats NTRK fusion-positive tumors and scored an FDA approval in November 2018.
While Japan is the first country to sign off on Roche's Rozlytrek, the company has also grabbed priority reviews and designations in the U.S. and Europe. Aside from the med's initial nod, authorities in Japan are also reviewing the product to treat patients with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer.
Biomarker testing is the only way to determine whether patients could benefit from the therapy, and to that end, Roche has a companion diagnostic under review. Jefferies analysts have predicted $700 million in peak global sales for the new drug.
As Roche ramps up its global efforts with Rozlytrek, it’ll be challenging Bayer’s Vitrakvi, which is among the first "tumor-agnostic" drugs to nab a U.S. approval. Bayer and Loxo Oncology developed the med together, but Eli Lilly purchased Loxo and Bayer scooped up Vitrakvi rights.
Bernstein analyst Wimal Kapadia has predicted peak sales of €900 million for Vitrakvi, but he cautioned that Roche’s med remains a threat. For one, he said, “any decent cancer drug in Roche's hands becomes interesting." Roche’s Rozlytrek has posted better data in central nervous system tumors, the analyst wrote, but the “NTRK mutation is not the only target” for Roche’s med, so that may boost Vitrakvi.
The approval for Roche comes as its three top sellers—Rituxan, Herceptin and Avastin—near the end of their patent lives. Roche has predicted they could face U.S. biosimilar competition in 2019. Aside from Rozlytrek, the drugmaker also recently won a nod for first-in-class lymphoma drug Polivy, and it has other big launches underway in Hemlibra for hemophilia and Ocrevus for multiple sclerosis.
In addition to Roche’s med, Japan’s MHLW on Tuesday also signed off on Alexion’s Ultomiris, Daiichi Sankyo’s Vanflyta and Alnylam’s Onpattro. Daichii said its med, which in May failed to score backing from an FDA advisory committee, is the first of seven new cancer therapies it expects to launch through 2025.