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Genentech's Rozlytrek Garners FDA Approval in NTRK-Positive Cancers for Adults, Adolescents

NEW YORK – The US Food and Drug Administration has granted accelerated approval to entrectinib (Genentech's Rozlytrek) as a treatment for adult and adolescent patients whose cancers have NTRK gene fusions and are out of treatment options.  

This is the third drug the agency has approved with a pan-cancer indication. Previously, pembrolizumab (Merck's Keytruda) for solid tumors with high microsatellite instability and mismatch repair deficiency, and larotrectinib (Bayer and Loxo Oncology's Vitrakvi) in solid tumors with NTRK fusions, garnered tissue-agnostic indications. 

"We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue-agnostic therapies, which have the potential to transform cancer treatment," FDA Acting Commissioner Ned Sharpless said in a statement. "We're seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine." 

The FDA approved the drug based on data from four trials involving 54 adults with NTRK-positive tumors, with lung, salivary gland, breast, thyroid, and colon/rectum cancers being most common. In these studies, 57 percent saw their tumors shrink, and 7.4 percent saw their tumors completely disappear. Of the 31 patients who responded, 61 percent experienced tumor shrinkage for nine months or longer. 

Richard Pazdur, director of the FDA's Oncology Center of Excellence, highlighted in a statement that the approval allows entrectinib to be used by young patients 12 years and older. The efficacy of the drug was studied in 30 pediatric patients.

The FDA simultaneously also approved entrectinib for adults with metastatic non-small cell lung cancer whose tumors are ROS1-positive. The approval was based on a study involving 51 adults with ROS1-positive lung cancer, in which 78 responded and nearly 6 percent had a complete response. Out of 40 responders, 55 percent experienced tumor shrinkage for 12 months or longer.