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Entrectinib Approved by FDA for ROS1-Positive NSCLC

By: Sarah Jackson
Posted: Friday, August 16, 2019

Yesterday, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for the treatment of adults with metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Entrectinib was also approved for treatment of adult and adolescent patients whose cancers have an NTRK  (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments.

This is the third time the FDA 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. The approval marks a new paradigm in the development of cancer drugs that are “tissue-agnostic.” It follows the policies that the FDA developed in a guidance document released in 2018. The previous tissue-agnostic indications approved by the FDA were pembrolizumab for tumors with microsatellite instability–high or mismatch repair–deficient tumors in 2017 and larotrectinib for NTRK gene fusion tumors in 2018.

Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having a complete response. Among the 40 responding patients, 55% had a response persist for at least 12 months.

The efficacy of entrectinib was also evaluated in four clinical trials of 54 adults with NTRK  fusion–positive tumors. The overall response rate was 57%, with 7.4% having a complete response. Among the 31 responding patients, 61% had a response persist for at least 9 months. The most common cancer locations were the lung, salivary gland, breast, thyroid, and colon/rectum.

Common side effects associated with entrectinib are fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, weight gain, cough, vomiting, fever, arthralgia, and vision disorders. The most serious side effects reported with the use of entrectinib are congestive heart failure, central nervous system effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision disorders.



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