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

Nuvation Bio Expands Access to Taletrectinib for Advanced ROS1-Positive NSCLC Patients in the U.S.

Nuvation Bio a leading global biopharmaceutical company focused on developing innovative therapies for some of the most pressing unmet needs in oncology, has announced the initiation of an Expanded Access Program (EAP) in the United States for taletrectinib. The program is designed to provide patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) access to taletrectinib when no comparable or satisfactory alternative therapy options are available.

Dr. David Hung, Founder, President, and Chief Executive Officer of Nuvation Bio, emphasized the company’s unwavering commitment to patients, stating, “This EAP reflects our dedication to addressing the urgent needs of individuals battling ROS1-positive NSCLC. We remain committed to collaborating with the ROS1-positive NSCLC community and healthcare providers to ensure that eligible patients in the U.S. can access taletrectinib efficiently outside of our clinical trials.”

Understanding the Significance of the Expanded Access Program

The introduction of an Expanded Access Program is a significant step in ensuring that patients facing serious or immediately life-threatening diseases have access to promising investigational treatments. The U.S. Food and Drug Administration (FDA) has authorized this EAP to provide access to taletrectinib for patients who do not have viable alternative treatments and who meet specific eligibility criteria.

Expanded Access Programs serve as a bridge for patients who may not be able to participate in clinical trials due to strict inclusion criteria, geographic limitations, or other medical considerations. By offering taletrectinib under this program, Nuvation Bio aims to fill a crucial gap for ROS1+ NSCLC patients who have exhausted other options.

The Challenge of ROS1-Positive NSCLC

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. Within this category, ROS1-positive NSCLC is a rare subset, occurring in approximately 1-2% of patients. Although relatively uncommon, ROS1-positive NSCLC presents unique challenges in diagnosis and treatment due to its distinct genetic profile and the limited number of effective therapies available.

ROS1+ NSCLC is driven by a genetic rearrangement involving the ROS1 gene, which leads to the production of an abnormal protein that promotes cancer cell growth. Targeted therapies such as tyrosine kinase inhibitors (TKIs) have emerged as a standard treatment approach; however, resistance to these treatments can develop over time, necessitating new therapeutic options.

How Taletrectinib Addresses Unmet Needs

Taletrectinib is an investigational next-generation ROS1 inhibitor designed to overcome resistance mechanisms seen in current ROS1-targeting therapies. The drug has demonstrated promising efficacy and safety in clinical trials, showing robust responses in both treatment-naïve patients and those who have developed resistance to other ROS1 inhibitors.

Nuvation Bio’s Expanded Access Program ensures that taletrectinib reaches eligible patients sooner, providing an opportunity for those who may not otherwise have access to this innovative therapy. This is especially crucial for individuals who have progressed on previous treatments or who are ineligible for ongoing clinical trials.

Voices from the ROS1+ NSCLC Community

Janet Freeman-Daily, Co-Founder and President of The ROS1ders, an advocacy group dedicated to supporting patients with ROS1-positive cancers, praised the launch of the EAP.

“ROS1-positive NSCLC is a rare form of lung cancer with a unique patient journey to navigate. 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,” said Freeman-Daily. “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.”

Her statement underscores the critical role that programs like this play in ensuring patients receive the best possible care, even when they fall outside traditional clinical trial parameters.

Regulatory Milestones and Clinical Data

In December 2024, the U.S. FDA accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib as a treatment for advanced ROS1+ NSCLC, regardless of prior treatment history (line agnostic). The application was granted Priority Review status, with the FDA setting a Prescription Drug User Fee Act (PDUFA) target action date of June 23, 2025. This means that if approved, taletrectinib could soon become a widely available treatment option for patients in need.

The NDA submission is based on robust clinical data from the pivotal Phase 2 TRUST-I and TRUST-II studies, which were presented at the European Society of Medical Oncology (ESMO) Congress in September 2024. These studies demonstrated significant anti-tumor activity and favorable safety profiles in both TKI-naïve patients and those previously treated with other ROS1 inhibitors.

Key findings from the TRUST studies include:

  • High overall response rates (ORR) in treatment-naïve patients and those with prior ROS1 inhibitor exposure.
  • Durable responses and prolonged progression-free survival (PFS), even in patients with central nervous system (CNS) metastases.
  • A manageable safety profile with lower rates of severe adverse events compared to other ROS1 inhibitors.

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