FDA Prioritizes Review of Nuvation Bio's Taletrectinib for Advanced ROS1-positive Lung Cancer

Nuvation Bio Inc., a prominent player in the global biopharmaceutical landscape, has announced a significant development in the fight against a specific type of lung cancer. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for taletrectinib, an innovative next-generation ROS1 tyrosine kinase inhibitor (TKI). This investigational drug is aimed at treating advanced ROS1-positive non-small cell lung cancer (NSCLC), a condition for which there are currently limited treatment options. The FDA has granted Priority Review status to this application, setting a Prescription Drug User Fee Act (PDUFA) target date for June 23, 2025. This designation highlights the potential of taletrectinib to address a significant unmet need among patients with this type of cancer.

David Hung, M.D., Founder, President, and CEO of Nuvation Bio, expressed excitement over this milestone. He emphasized the potential of taletrectinib to offer durable and meaningful benefits to patients, supported by data from over 300 individuals—the most extensive dataset for ROS1-positive NSCLC to date. Since acquiring AnHeart Therapeutics earlier this year, Nuvation Bio has been committed to advancing taletrectinib towards U.S. regulatory approval. The FDA’s decision to grant Priority Review is a testament to the strong clinical data supporting the drug and its promise for patients in need.

The NDA submission is backed by results from the pivotal Phase 2 TRUST-I and TRUST-II studies, which were showcased at the European Society of Medical Oncology (ESMO) Congress in 2024. These studies evaluated the efficacy and safety of taletrectinib in treating advanced ROS1-positive NSCLC. Taletrectinib is designed as an oral, potent, and selective inhibitor targeting the central nervous system, showing promise for patients at various stages of treatment.

Taletrectinib has already received Orphan Drug Designation from the U.S. FDA for its intended use in ROS1-positive NSCLC and additional NSCLC indications. Furthermore, it has been granted Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for treating patients with locally advanced or metastatic ROS1-positive NSCLC. The TRUST studies have collectively demonstrated the drug’s potential, leading to its acceptance for Priority Review by the U.S. FDA for advanced ROS1-positive NSCLC.

The TRUST-I and TRUST-II trials have provided critical data, pooling results from 337 patients with advanced ROS1-positive NSCLC who received taletrectinib. The studies focused on several endpoints, including the confirmed objective response rate (cORR) assessed by an independent review committee, intracranial cORR, duration of response, progression-free survival, and overall safety.

ROS1-positive NSCLC represents a small yet significant subset of lung cancer, affecting approximately 2% of those diagnosed with non-small cell lung cancer globally. This type of cancer is known for its propensity to metastasize to the brain, particularly in individuals whose disease has progressed following initial treatment. Despite advancements in treatment, there remains a substantial need for more effective and tolerable options, which taletrectinib aims to address.

Nuvation Bio, founded in 2018 by Dr. David Hung, is devoted to addressing unmet needs in oncology through innovative therapies. The company’s portfolio features not only taletrectinib but also other promising candidates such as safusidenib, NUV-1511, and NUV-868. With offices in major cities across the globe, including New York and Shanghai, Nuvation Bio remains dedicated to its mission of developing novel treatments to improve patient outcomes in cancer.