On August 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, AUG 11, 2021, View Source [SID1234586469]).
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The Fast-Track designation was granted for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with one prior ROS1 tyrosine kinase inhibitor (TKI) and who have not received prior platinum-based chemotherapy.
"We are pleased to receive our fourth Fast-Track designation and sixth overall regulatory designation for repotrectinib as we continue to work toward our goal of getting this ROS1 targeted therapy to patients quickly," said Athena Countouriotis, M.D., president and chief executive officer. "We continue to believe repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive advanced non-small cell lung cancer or NTRK-positive advanced solid tumors and now have multiple regulatory designations in both the TKI-naïve and TKI-pretreated ROS1 patient populations."
Repotrectinib was previously granted Breakthrough Therapy designation in ROS1- positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as three Fast-Track designations in ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve, ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments.
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 the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication with the FDA;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling submission of a New Drug Application (NDA) for review by FDA.