On August 24, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, AUG 24, 2020, View Source [SID1234564367]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK tyrosine kinase inhibitors (TKIs) and have no satisfactory alternative treatments. Repotrectinib was previously granted two Fast Track designations for the treatment of ROS1-positive advanced non-small cell lung cancer patients, first for patients with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and second for patients without prior ROS1 TKI treatment. There are no approved targeted therapies for patients previously treated with another ROS1 or TRK TKI.
"We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors and are pleased to receive our third Fast-Track designation that may help expedite its development," said Athena Countouriotis, M.D., president and chief executive officer. "NTRK-driven cancers are estimated to occur in up to 50,000 patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI."
Turning Point recently reported early interim data from its registrational Phase 2 TRIDENT-1 study of repotrectinib, showing a confirmed objective response rate of 50 percent (3/6) in the cohort of NTRK-positive TKI-pretreated advanced solid tumor patients. A total of 40 patients are planned for enrollment in this cohort, and the FDA recently provided guidance that 6 months of follow up from the last response in this cohort may be sufficient to support potential approval. Previous guidance was 12 months. This recent guidance and Fast-Track designation may provide a faster path to potential approval.
About Fast Track Designation
Fast Track is an FDA program intended to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.
A drug candidate that receives Fast Track designation may be eligible for:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication with FDA;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
Rolling submission of a New Drug Application (NDA) for review by FDA.