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# Genentech’s Rozlytrek Approved for 2 Cancer Indications
- URL: https://www.fdaweb.com/genentechs-rozlytrek-approved-for-2-cancer-indications/
- Published: 2019-08-15T12:00:00.000Z
- Updated: 2026-09-15T01:44:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144783

FDA has granted accelerated approval for Genentech’s Rozlytrek (entrectinib) foe treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. The drug also was approved for treating adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and has spread to other parts of the body.

“This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated,” an [FDA release](http://www.marketwatch.com/story/fda-approves-genentechs-rozlytrek-entrectinib-for-people-with-ros1-positive-metastatic-non-small-cell-lung-cancer-and-ntrk-gene-fusion-positive-solid-tumors-2019-08-15?ref=fdaweb.com) says. “The approval marks a new paradigm in the development of cancer drugs that are ‘tissue agnostic.’”

FDA says the approval follows policies that the agency developed in a 2018 [guidance document](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocdbgAcp7Tmw9vphsxnocI2miPyGk7dr9FDE2xUJZU7E03IQmgVyHZ4xo6ELD1NSf7gLcpKVzTLqzT-2BxcjpXtMaHk1V8HUq6-2BBiKdCF38CX6THmBLcKIF-2FysibU-2FDeVADHq9jxbllS8ddP-2F0QWhiIAPwgj48CRUwqVYnPf53hUT6xqU2vnojA4ztrp-2FG4y-2FGJRzvetc7Q6o3vYmJFOONH6ew1ZXP7aI9Zb0bi0aovX-2FY6Cc3cqeKrfu9yaLEDXgya1m-2FJqDFCht1HAAmYwT-2F8Jkm6LfswUAd-2B1EATTUMi-2F96g-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuG7SImroJ7BLZF39beP5tbRaIHX1g9YSct-2BTlDdPhvgCzGQfsZ-2BokFeN-2BN5Cr1CTRIHPudUTLYlXRzkcwavuYDWmsJi0rFbaRdngB7bDaNlzIAQM9gTVmi56oXNdzaXulyNkyGpp8VS0ngMttfsui8liR5IaYfs-2Fmppj5q-2Fn3w-2F6Gr9-2F-2B7nuaqEd1PpGfIqimdgOmojEXxupQ5U6MoYaQdmmYpD6JqWRKCBhUtxjIyQrEsU9qPD0qq12OeA9AG36E3FBYIYPfThyVnR-2FsFBRuD21UbQHJrtkxm2wbKY9vlAM-3D&ref=fdaweb.com). Previous tissue agnostic indications approved by FDA were for Merck’s Keytruda ([pembrolizumab](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocdbgAcp7Tmw9vphsxnocI2ciEwwcRF9aORxWxJZcgypYAds2c7czTw9GljMY-2FoFy2z9fDJt7fhBVhhaLdxSEaM4sM6mS2-2Fq0rIExGP0cT3qG6TNMDpwfQUtevfuxpF9D1Xbvx3CaXVL6moSrxfTbVRxY1tBTv-2F6QJ1-2B8mo0hTRdM3P7zPnY3Jwb2b-2B9T85MUCZSC9vs0OxYpr24pi-2BlkCdJ8NcC88ntyF4V-2FZMMFMpBayfGBlKZVkq6XCnVp35-2Bfc-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuG7SImroJ7BLZF39beP5tbRaIHX1g9YSct-2BTlDdPhvgCzGQfsZ-2BokFeN-2BN5Cr1CTRIHPudUTLYlXRzkcwavuYDWmsJi0rFbaRdngB7bDaNlzIAQM9gTVmi56oXNdzaXulyNkyGpp8VS0ngMttfsui8lQQjsRwJG3rLNgvYIuD1aOhFTmIgBCy-2F4Qc0AhcrnPCXdEv0LbRFmuagC0WsUGR4DVM-2FtWSkEIK0MOSDE-2FOwPviEQJYTRKLfpjKqZTsxx5-2FH-2FvMdSz1vxVld5S5-2FbvCmVmZY07nN0FAiAXe4S67z20-3D&ref=fdaweb.com)) for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017, and Bayer and Loxo Oncology’s Vitrakvi ([larotrectinib](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocdbgAcp7Tmw9vphsxnocI2qY6Ivj70F27XTfeoMHhqSyIWa2JRlRdoFz2JDjty5f9pqE4jAWPAjjjGk3br9C9IcoiN4-2FUuit4Y8L1Ra68R65bgIzfVdQDrPm4ma89ZnR4b3IXd7jlIBOauYwJ4wQu9h1d8QaforI9Y-2FSl7Q74ni4EF1Qaw3RU9tE73L8hMrRgJ1-2FcEU4DBD-2F5ApDR645ks60ZqL4GYxwtZcIrr7FJIz3xCIusNEOBqK-2B9mpFcnwFJTbgqhzUhaBMsUs69VtfnY%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuG7SImroJ7BLZF39beP5tbRaIHX1g9YSct-2BTlDdPhvgCzGQfsZ-2BokFeN-2BN5Cr1CTRIHPudUTLYlXRzkcwavuYDWmsJi0rFbaRdngB7bDaNlzIAQM9gTVmi56oXNdzaXulyNkyGpp8VS0ngMttfsui8kM6M21xwWNMZq1-2BOiEG3iM4Y8PfxEQuofNN1zB7lVguZdBfpH9fNt9zwPy0DIgA3LRpkeGSA-2Fi1US-2FRMwCLNNNa9lGotXgfKpZWdF5EtvpA8qtbxBdIZPYpsmWekW0Fg4Cgy38yrngA7RucNvObtog-3D&ref=fdaweb.com)) for NTRK gene fusion tumors in 2018.

Unlike traditional cancer drug approvals, Rozlytrek’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK fusion-positive tumors by relying on efficacy information obtained primarily in adults, FDA says. “Efficacy in adolescents was derived from adult data and safety was demonstrated in 30 pediatric patients,” it says.

Rozlytrek’s ability to shrink tumors was evaluated in four clinical trials studying 54 adults with NTRK fusion-positive tumors. “The proportion of patients with substantial tumor shrinkage (overall response rate) was 57%, with 7.4% of patients having complete disappearance of the tumor,” FDA says. “Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for nine months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid and colon/rectum.”

For lung cancer, Rozlytrek was evaluated in 51 adults with ROS1*\-*positive lung cancer. “The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer,” the agency says. “Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.”