Eisai and Nuvation Bio have announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib, a next-generation oral therapy for patients with advanced ROS1-positive Non-Small Cell Lung Cancer (NSCLC). The application will now proceed under the agency’s standard review timeline.

Taletrectinib, marketed as Ibtrozi in the United States and Japan, is a highly selective ROS1 inhibitor designed to target tumours driven by ROS1 gene rearrangements. The therapy is being positioned as a potential new standard of care for patients with this rare but aggressive subtype of lung cancer.

The submission is supported by data from the pivotal phase III TRUST-I and TRUST-II clinical studies, which evaluated the drug’s safety and efficacy in global patient populations. Results from the pooled analysis of these trials were previously published in the Journal of Clinical Oncology, demonstrating durable responses in patients treated with taletrectinib.

The validation marks a key milestone in the companies’ global development strategy, following a licensing and collaboration agreement signed in early 2026 to expand the drug’s reach across Europe and other international markets. Additional regulatory filings are planned in the United Kingdom, Canada and other regions covered under the agreement.

According to company estimates, nearly 400,000 people are diagnosed with lung cancer annually across Europe, with NSCLC accounting for around 80 percent of cases. Approximately 2 percent of these patients have ROS1-positive disease, which is often associated with high rates of metastasis, including spread to the brain.

Terushige Like, Chief Business Officer at Eisai, said the validation represents an important step toward expanding access to targeted therapies for patients with limited treatment options. 

Meanwhile, David Hung, Founder and CEO of Nuvation Bio, highlighted the milestone as part of the company’s broader effort to bring innovative cancer treatments to global markets.

Taletrectinib has already received full approval from the U.S. Food and Drug Administration in 2025 for the treatment of locally advanced or metastatic ROS1-positive NSCLC, following priority review and breakthrough therapy designations. The drug is also approved in Japan and China.

The TRUST clinical programme continues to expand, with additional phase III studies underway to further evaluate the therapy’s long-term benefits and potential use in earlier stages of the disease.