Nuvation Bio Launches Expanded Access Program in the U.S. for Taletrectinib in ROS1+ NSCLC

04 February 2025 | Tuesday | News


FDA-authorized program provides eligible patients with locally advanced or metastatic ROS1-positive lung cancer access to investigational therapy outside clinical trials
Image Source : Public Domain

Image Source : Public Domain

Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology,  announced it has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S. for the treatment of patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) when no comparable or satisfactory alternative therapy options are available.

“This EAP reflects our unwavering dedication to patients with ROS1-positive NSCLC,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials.”

The EAP, as authorized by the U.S. Food and Drug Administration (FDA), allows patients with serious or immediately life-threatening ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal Phase 2 TRUST-II study.

“ROS1-positive NSCLC is a rare form of lung cancer with a unique patient journey to navigate,” said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. “At The ROS1ders, we are constantly working toward our goal of improving survival and quality of life for the ROS1-positive cancer community by encouraging the research, development, and commercialization of effective treatments. Despite recent progress, there are times when approved therapies have not provided sufficient benefit or when patients are not eligible for a clinical trial. EAPs represent an opportunity for patients and their families to access investigational drugs that would not have otherwise been available to them.”

In December 2024, the U.S. FDA accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. The NDA 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) Congress in September 2024.

News

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close