NEW YORK – The US Food and Drug Administration has accepted Nuvation Bio's new drug application (NDA) seeking approval for taletrectinib as a line-agnostic treatment for advanced ROS1-positive non-small cell lung cancer, the company announced last week.
The FDA has granted Nuvation's NDA priority review and will aim to issue a decision on the application by June 23, 2025. Taletrectinib also has orphan drug and breakthrough therapy designations from the agency.
New York-based Nuvation submitted pooled data in its NDA from the Phase II TRUST-1 and TRUST-II trials, which are still being conducted. As of June 7, 337 patients with advanced ROS1-positive NSCLC received taletrectinib in these studies, and the objective response rate was 89 percent in tyrosine kinase inhibitor (TKI)-naïve patients and 56 percent in those who previously received a TKI. After a median follow-up of 21 months, the median duration of response and median progression-free survival in TKI-naïve patients was 44 months and 46 months, and 17 months and 10 months in TKI-pretreated patients, respectively.
Taletrectinib's previous developer, AnHeart Therapeutics, along with its Chinese partner, Innovent Biologics, previously filed applications seeking taletrectinib's approval in China in TKI-pretreated and treatment-naïve ROS1-positive NSCLC patients. Nuvation acquired AnHeart in April.
Since that acquisition, "we have executed on our plan to advance taletrectinib toward a full US regulatory approval," Nuvation Founder, President, and CEO David Hung said in a statement, adding that the company is establishing its commercial operations in preparation to launch taletrectinib on the market by as early as mid-2025.