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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer
  
  	
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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On November 15, 2023, the FDA approved repotrectinib (brand name Augtyro) for locally advanced or metastatic ROS1-positive non-small cell lung cancer.

This is the first FDA approval that includes patients with ROS1-positive non-small cell lung cancer who have previously received a ROS1 tyrosine kinase inhibitor, in addition to patients who are tyrosine kinase inhibitor naïve.

Approval was based on TRIDENT-1, a global, multicenter, single-arm, open-label, multi-cohort clinical trial which included patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer. Efficacy was evaluated in 71 ROS1 tyrosine kinase inhibitor-naïve patients who received up to 1 prior line of platinum-based chemotherapy and/or immunotherapy and 56 patients who received 1 prior ROS1 tyrosine kinase inhibitor with no prior platinum-based chemotherapy or immunotherapy.

The major efficacy outcome measures were overall response rate and duration of response according to RECIST v1.1 as assessed by blinded independent central review. Confirmed overall response rate in the ROS1 tyrosine kinase inhibitor naïve group was 79% and 38% in those patients receiving prior treatment with a ROS1 inhibitor. Median duration of response was 34.1 months and 14.8 months in the two respective groups. Responses were observed in intracranial lesions in patients with measurable central nervous system metastases, and in patients with resistance mutations following tyrosine kinase inhibitor therapy.

The most common adverse reactions reported in more than 20% of patients were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive disorders, and muscular weakness.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Health care professionals should report serious adverse events to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Follow the Division of Drug Information on X (formerly Twitter) @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning in to the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      01/05/2024Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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