Nuvation Bio Announces Expanded Access Program in the US for Taletrectinib in Advanced ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio Inc. recently announced it has initiated an Expanded Access Program (EAP) for taletrectinib in the US 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, MD, 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 US 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 US FDA accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1+ NSCLC (line agnostic). The US 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.

EAPs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical treatment outside of clinical trials and before it is approved by the US FDA. The EAP for taletrectinib may be available for patients with locally advanced or metastatic ROS1+ NSCLC who, in the opinion of the treating clinician, are not appropriate candidates for approved ROS1 targeted therapies and ongoing taletrectinib clinical studies. For additional information on Nuvation Bio’s clinical trials and EAP, please visit https://www.nuvationbio.com/for-patients or contact earlyaccess@nuvationbio.com.

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.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the US 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) and assigned a PDUFA goal date of June 23, 2025. The US FDA previously 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. In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

Each year, more than 1 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 patients 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.

Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com.