Roche's Rozlytrek gains first global approval with clearance in Japan for NTRK fusion-positive, advanced recurrent solid tumours

Roche announced Tuesday that Rozlytrek (entrectinib) gained clearance from Japan's Ministry of Health, Labour and Welfare for the treatment of adult and paediatric patients with NTRK fusion-positive, advanced recurrent solid tumours. The company noted that the approval is the first globally for Rozlytrek, while it is also the first tumour-agnostic medicine authorised in Japan that targets NTRK gene fusions.

Sandra Horning, Roche's head of global product development, said the decision "represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines that target cancers based on their molecular drivers instead of their location in the body." Rozlytrek is also under regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small-cell lung cancer.

Roche noted that approval of Rozlytrek was mainly supported by data from the pivotal Phase II STARTRK-2 study, with results showing that the oral drug shrank tumours in 56.9% of people with NTRK fusion-positive solid tumours, across 10 different tumour types, including those with central nervous system metastases. The filing also included data from the Phase I STARTRK-1 and ALKA-372-001 trials, as well as the Phase I/Ib STARTRK-NG study, which was recently presented at the American Society of Clinical Oncology (ASCO) annual meeting.

Rozlytrek, previously known as RXDX-101, is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins. Earlier this year, the FDA granted priority review to filings seeking approval of the drug to treat certain adult and paediatric patients with NTRK fusion-positive, locally advanced or metastatic solid tumours, and to treat patients with metastatic ROS1-positive non-small-cell lung cancer.

Last year, Bayer's Vitrakvi (larotrectinib) became the first drug approved globally to treat adult and paediatric patients with tumours harbouring an NTRK gene fusion, with the oral TRK inhibitor cleared in the US.

For related analysis, see ViewPoints: ASCO19- Next generation TRK inhibitors in the spotlight, and Physician Views snap poll results: Are oncologists ready for the latest evolution in biomarker-driven cancer care?

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