Nuvation Bio to Present Updated Data on Taletrectinib, a ROS1 inhibitor, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Innovent and AnHeart Announce the NMPA Has Accepted NDA for Taletrectinib
AnHeart and Innovent Announce NMPA Has Granted Taletrectinib Priority Review
AnHeart Therapeutics and Foundation Medicine Announce Collaboration
AnHeart Therapeutics Announces Exclusive License Agreement With Nippon Kayaku for Taletrectinib in Japan
NEW YORK--(BUSINESS WIRE)--AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced positive interim results from its global pivotal Phase 2 clinical trial, TRUST-II. Interim data from the trial showed taletrectinib, AnHeart’s investigational next-generation ROS1 inhibitor, shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 92% of patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who had not previously been treated with a ROS1 tyrosine kinase inhibitor (TKI naïve). Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated). Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
NEW YORK & SEOUL, South Korea--(BUSINESS WIRE)--AnHeart Therapeutics and NewG Lab Therapeutics, a subsidiary of NewG Lab Pharma, announced that the Ministry of Food and Drug Safety (MFDS), Republic of Korea has granted the Designation of Orphan Drug (ODD) to taletrectinib, a next generation tyrosine kinase inhibitor (TKI) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.
AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, today announced the appointment of Shuanglian (Lian) Li, M.D., Ph.D., as the company’s Senior Vice President and Chief Medical Officer (US). In this role, Dr. Li will oversee and direct all U.S.-based clinical programs.
NEW YORK--(BUSINESS WIRE)--AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, jointly announced today updated efficacy and safety data from the Phase 2 TRUST clinical trial of taletrectinib in patients with ROS1-positive non-small cell lung cancer (NSCLC), at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.