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news.China's National Medical Products Administration (NMPA) has granted approval to the second new drug application (NDA) of Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI), DOVBLERON (taletrectinib adipate capsule) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The therapy is intended to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer in adults. Credit: Robina Weermeijer on Unsplash.
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This decision follows the positive outcomes from the multicentre, open-label Phase II TRUST-I trial.
The single-arm trial was instrumental in assessing the therapy’s tolerability, efficiency, and safety in Chinese subjects.
Its outcomes indicated that the therapy provided ‘high and durable’ overall responses, particularly showing ‘robust’ activity against intracranial lesions in subjects with this condition.
Innovent Biologics senior vice-president Dr Hui Zhou said: “The two NDAs approval of DOVBLERON is a reflection of its potential best-in-class efficacy to fulfil the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON to market, rapidly bringing this precision therapy to NSCLC patients who need novel treatment options.
“Innovent’s robust TKI product pipeline—including RETSEMOV, PEMAZYRE, DUPERT and DOVBLERON—showcases our leadership and synergistic strengths in precision oncology. We endeavour to advance more innovative medicines to enhance patients’ quality of life.”
Last month, the therapy received its initial approval by the NMPA for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who had priorly been treated with ROS1 TKIs. It is currently the 13th product in the company’s commercial lineup.
The current approval marks an expansion of the therapy’s indication.
In June 2021, the company entered into a strategic collaboration with Nuvation Bio company, AnHeart Therapeutics (Hangzhou). The exclusive license agreement covers the co-development and commercialisation of the therapy in Greater China, which includes mainland China, Macau, Taiwan, and Hong Kong.
