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Roche Receives FDA Nod for Rozlytrek in ROS1-positive NSCLC

Zacks Equity Research

Roche Holdings RHHBY announced that the FDA has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients aged 12 years or older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

The agency’s accelerated approval program allows conditional approval of a drug that fills an unmet medical need for a serious or life-threatening disease or condition. Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trial.

The FDA approval was based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.

Per the company, Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and showed responses in various cancer types that have spread to the brain.

Meanwhile, Roche is leveraging its expertise in developing personalized medicines and advanced diagnostics in conjunction with Foundation Medicine to help identify patients with ROS1 and NTRK gene fusions.

Foundation Medicine will submit Foundation One CDx to the FDA for approval as a companion diagnostic for Rozlytrek.

Rozlytrek was approved in June 2019 in Japan for the treatment of adult and pediatric patients with NTRK fusion-positive, advanced recurrent solid tumors. The drug has also been granted Priority Medicines (PRIME) designation by the European Medicines Agency.

The approval of Rozlytrek in the United States will strengthen Roche’s oncology franchise. The company currently has five approved drugs (Tarceva, Avastin and Tecentriq, among others) to treat certain kinds of lung cancer and more than 10 candidates in the pipeline to target the most common genetic drivers of lung cancer or boost the immune system to combat the disease.

Lung cancer is one of the most prevalent cancers and the leading cause of cancer-related death across the world. More than one and a half million patients die as a result of this disease globally, equating to more than 4,000 deaths every day. NSCLC is the most common type of lung cancer and accounts for 85% of all lung cancer diagnoses.

Roche’s stock has gained 11.2% in the year so far against the industry’s decline of 3.6%.


However, competition is stiff in the NSCLC market. Immuno-oncology therapies like Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi and Bristol-Myers’ BMY Opdivo are approved for various types of NSCLC.

Roche currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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