Japanese regulators say ‘engage’ on Roche’s Trk inhibitor

The FDA is expected to reach a decision by August on the drug, Rozlytrek, a tumor-agnostic cancer drug and potential competitor to Bayer’s Vitrakvi.

Roche’s headquarters in Basel, Switzerland

A drug from Roche designed to treat solid tumors based on a genetic marker rather than where they occur in the body has won regulatory approval. But so far, it’s only in Japan.

The Swiss drugmaker said Tuesday that Japan’s Ministry of Health, Labour and Welfare approved Rozlytrek (entrectinib) for patients with advanced, recurrent solid tumors that harbor NTRK fusions. The approval is based on results from the Phase II STARTRK-2 trial, which showed that more than half of patients receiving the drug saw shrinkage in their tumors.

The decision marks the first approval for the drug and the second approval globally for a drug targeting cancers with NTRK fusions. The first was the November 2018 U.S. Food and Drug Administration approval of Loxo Oncology and Bayer’s Vitrakvi (larotrectinib), also for NTRK fusion-positive solid tumors. Indianapolis-based Eli Lilly & Co. acquired Loxo in January for $8 billion. Vitrakvi itself was the second drug to receive a tumor-agnostic label, the first being Merck & Co.’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) for microsatellite instability-high and mismatch repair deficiency solid tumors, in May 2017, though Vitrakvi was the first drug to win a tumor-agnostic indication as its sole label.

Roche’s approval applications are also under priority review from the FDA and the European Medicines Agency.

According to the STARTRK-2 data, Rozlytrek shrank tumors in 56.9 percent of patients. For FDA approval, Roche submitted data from STARTRK-2 along with two Phase I trials and a Phase I/Ib study, and the agency plans to make a decision on whether or not to approve it by August.

Given that NTRK fusions are spread thin across a wide variety of tumors, finding them is likely to present a challenge, though one that is ameliorated by the increasing prevalence of genomic sequencing of cancer patients. Relative to Vitrakvi, which only targets NTRK fusions, a potential advantage for Rozlytrek is that it also targets ALK and ROS1 fusions.

Photo: Roche