Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval on Nov. 15, 2023, for Augtyro^™ (repotrectinib) capsules. The tyrosine kinase inhibitor (TKI) is indicated to treat adults who have advanced cases of non-small cell lung cancer (NSCLC) that have tested positive for the proto-oncogene, ROS1. The recommended dose is 160mg (four capsules) once a day for two weeks, then it increases to 160mg twice a day. The launch is planned for the middle of December 2023. Augtyro’s estimated cost is not yet available. Here is the full prescribing information.

At a Glance

• Brand (Generic) Name: Augtyro (repotrectinib)
• Manufacturer: Bristol Myers Squibb
• Date Approved: Nov. 15, 2023
• Indication: to treat patients who have locally advanced or metastatic ROS1-positive NSCLC
• Dosage Forms Available: 40mg oral capsules
• Launch Date: by mid-December 2023
• Estimated Annual Cost: Pricing information is not yet available.
• According to the American Cancer Society (ACS), lung cancer is diagnosed to about 240,000 Americans, annually, and NSCLC accounts for up to 85% of all lung cancer cases
• As estimated by the Lung Cancer Foundation of America, ROS1 mutations account for 2% or fewer of NSCLC cases. Patients are more likely to be never-smokers than other lung cancer patients. More women are affected than men and patients average about 20 years younger at diagnosis than other individuals who have lung cancer (approximately 51 years old vs 70 years old). As much as 40% of ROS1+ NSCLC metastasizes to the brain.
• By blocking the activity of ROS-1 and other tyrosine kinases, Augtyro decreases cancer cells’ ability to grow and spread.
• In an open-label phase II clinical study of 71 patients who had not had treatment with a TKI for their ROS1+ NSCLC, 79% of those who took Augtyro had at least some response to treatment, which lasted an average of 34.1 months.
• A second part of the trial involved 56 patients who previously had used a TKI that targets ROS1, but who had not had chemotherapy (chemo) or immunotherapy to treat their cancers. The overall response rate (ORR) was 38% and the average duration of response was 14.8 months.
• Serious side effects, such as hypoxia, pleural effusion, and pneumonia, caused Augtyro treatment to be stopped for 8% of patients and doses to be lowered for 35% of participants.
• More commonly, patients taking Augtyro experienced cognitive impairment, constipation, difficulty breathing, dizziness, fatigue, muscle weakness, and peripheral neuropathy.
• Two other TKIs are FDA-approved to treat ROS1+ NSCLC in adults. Xalkori® (crizotinib – Pfizer) capsules have been marketed in the U.S. since 2016, and Rozlytrek^® (entrectinib – Genentech) capsules and oral pellets since March 2019.