On January 6, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that China’s National Medical Products Administration (NMPA) has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI) (Press release, Nuvation Bio, JAN 6, 2025, View Source [SID1234649448]). As part of an exclusive license agreement, Innovent Biologics will commercialize taletrectinib in China under the brand name DOVBLERON. The product was officially launched in the territory in January 2025. Taletrectinib was previously granted Breakthrough Therapy Designation and Priority Review by China’s NMPA.
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The approval by China’s NMPA was based on data from the pivotal Phase 2 TRUST-I study of taletrectinib in patients in China, which were published in the Journal of Clinical Oncology and presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2024.
"Taletrectinib’s approval by the NMPA underscores its best-in-class potential, and Nuvation Bio’s commercialization partnership with Innovent Biologics in China brings us closer to our goal of addressing the critical needs of patients with ROS1-positive NSCLC worldwide," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are committed to bringing innovative cancer treatments to patients who need them most, and we look forward to building upon this momentum with the potential FDA approval and launch of taletrectinib in the U.S. in mid-2025."
As a reminder, in December 2024, the U.S. Food and Drug Administration (FDA) accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1-positive NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs. The NDA in the U.S. is based on the pooled results from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib, which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024.
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
The U.S. FDA has granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted for Priority Review Nuvation Bio’s NDA for taletrectinib for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval).
In 2021, AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio company, entered into an exclusive license agreement with Innovent Biologics (Suzhou) Co. Ltd. for the commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. Up to 35% of people newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.