Nuvation Bio Inc. (NUVB), a biopharmaceutical company, announced on Monday that it has received approval from China's National Medical Products Administration or NMPA for taletrectinib, an oral next-generation ROS1 inhibitor designed for patients with advanced ROS1+ non-small cell lung cancer.
The approval is based on data from the pivotal Phase 2 TRUST-I study, which demonstrated taletrectinib's durable responses and prolonged progression-free survival in patients.
Taletrectinib will be marketed in China by Innovent Biologics under the brand name Dovbleron. The product officially launched in January 2025.
The approval follows Nuvation Bio's collaboration with Innovent Biologics, to bring this innovative therapy to patients in China.
The approval of taletrectinib follows its previous Breakthrough Therapy Designation and Priority Review by the NMPA.
In addition to the Chinese approval, Nuvation Bio has received Priority Review from the U.S. FDA for taletrectinib, with a Prescription Drug User Fee Act goal date set for June 23, 2025.
The U.S. NDA for taletrectinib is based on pooled results from the Phase 2 TRUST-I and TRUST-II studies.
In 2021, Nuvation Bio entered into an exclusive license agreement with Innovent Biologics for the commercialization of taletrectinib in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.
Each year, over one million people are diagnosed with NSCLC, with approximately 2 percent of those cases being ROS1-positive. Despite advances in treatment, there remains a significant need for more effective and tolerable options for these patients.
Currently, NUVB is trading at $2.88 down by 0.17%.
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