FDA Approves Roche’s New Cancer Drug

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FDA has approved Roche’s new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.

On Aug. 16, 2019, Roche announced that FDA approved Rozlytrek (entrectinib) for treating adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). FDA has also granted accelerated approval to Rozlytrek for treating adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

“Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting,” said Sandra Horning, MD, Roche’s chief medical officer and head of Global Product Development, in a company press release. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”

FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumor response rate and durability of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.


In conjunction with Foundation Medicine, a Cambridge, MA-based genomics company, Roche will help identify people with ROS1 and NTRK gene fusions via biomarker testing, which is the only way to identify those who are eligible for treatment with Rozlytrek. Foundation Medicine will submit FoundationOne CDx, a companion diagnostic for Rozlytrek, to FDA for approval. An FDA-approved companion diagnostic for Rozlytrek is not available at this time, according to Roche.

Source: Roche