France Strengthens Cancer Access with TEVIMBRA and New 14-Day Trial Fast-Track

Breaking Down TEVIMBRA Access and the 14-Day Trial Pathway

France has taken two decisive steps to reinforce its clinical research ecosystem and expand access to new oncology therapies. The Haute Autorité de Santé (HAS) has issued a favourable reimbursement opinion for TEVIMBRA (tislelizumab) in gastric and oesophageal cancers, while the National Agency for the Safety of Medicines and Health Products (ANSM), in collaboration with national ethics bodies, has introduced a 14-day fast-track authorization pathway for early-phase and priority clinical trials beginning in early 2026.

Although distinct in scope, the paired actions highlight France’s strategic intent: accelerate development, improve market access, and strengthen the country’s position amid rising international competition in drug innovation.

What You Need To Know

HAS grants a favorable reimbursement opinion for TEVIMBRA within its approved gastric and esophageal cancer indications.
The decision follows earlier negative monotherapy assessments but now supports the combination setting for upper GI malignancies.
ANSM launches a national 14-day fast-track authorization pathway for early-phase and priority clinical trials beginning in Q1 2026.
Together, the moves strengthen France’s oncology access and improve competitiveness for first-in-class and innovative clinical research.

HAS grants positive reimbursement opinion for TEVIMBRA in upper GI cancers

HAS’ most recent decision confirms a favourable reimbursement status for TEVIMBRA within the approved EMA indications, specifically its use in combination with chemotherapy for gastric cancer and oesophageal cancer, within its marketing authorisation. The update marks a shift from earlier assessments, which had delivered negative opinions for monotherapy use in oesophageal squamous cell carcinoma in 2024. The new recommendation therefore completes a multi-step evaluation sequence that began with initial access denials and now culminates in reimbursement in the combination setting.

According to the HAS note, TEVIMBRA is now considered reimbursable for eligible patient populations under the French healthcare system, provided the usage aligns with the authorization. The review underscores continued scrutiny of comparative benefit (ASMR), with prior evaluations spanning ASMR scoring but ultimately concluding that reimbursement is justified in its current combination indication. For clinicians treating advanced gastric or oesophageal cancers areas with limited therapeutic momentum, the decision provides an additional immune-oncology option alongside established backbones.

The determination is meaningful given the high disease burden associated with upper GI malignancies and the historically narrow set of reimbursed immunotherapies available in France. With tislelizumab positioned as a PD-1 inhibitor designed to reduce Fc-gamma receptor binding, the therapy’s mechanism may offer differentiated performance compared to earlier-generation checkpoint inhibitors. The updated HAS stance signals regulatory openness to expanding competition in I/O where clinical rationale and combination data are sufficiently compelling.

France announces 14-day fast-track clinical trial authorizations

In a complementary policy development, the French government has announced a national fast-track system to accelerate trial authorization timelines to as little as 14 days beginning in Q1 2026 . The reform emerges from a coordinated effort among ANSM, the National Commission for Research Involving Human Subjects (CNRIPH), the National Conference of Ethics Committees (CNCP), DGOS, and the Health Innovation Agency (AIS).

The goal is clear: improve France’s attractiveness for early-phase and innovative clinical studies and provide patients with timelier access to cutting-edge therapies. The initiative specifically targets two groups:
• Early-phase clinical trials (Phase I or integrated I/II)
• Single-national trials that involve serious, rare, or disabling diseases without approved treatments; first-in-class mechanisms; or protocols facilitating adolescent inclusion into adult studies.

Under the current European rules, authorization timelines can extend beyond 100 days when questions are raised. The new model compresses evaluations significantly, 14 days for submissions without issues, and a maximum of 49 days when clarifications are required. Notably, the fast-track eliminates the additional 50-day delay historically required for Innovative Therapy Drugs.