FDA Delays Decision on BeiGene’s BLA for Tislelizumab

The FDA has not been able to complete inspections of facilities because of COVID-19 restrictions.

The FDA has deferred action on the biologics license application (BLA) for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. The FDA has been unable to conduct required inspections in China due to COVID-19 related travel restrictions.

The application remains under review, and the FDA did not provide a new action date.

“We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the United States following regulatory approval,” John V. Oyler, co-founder, chairman and CEO of BeiGene, said in a press release.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. It is first drug from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for a broad array of both solid tumor and hematologic cancers.

In September 2021, the FDA accepted the BLA for tislelizumab in second-line esophageal squamous cell carcinoma. The submission includes results from RATIONALE 302 phase 3 trial that enrolled 512 patients from Europe, United States, and Asia and safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials. The RATIONALE 302 trial demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared with chemotherapy in patients who had received prior systemic therapy. Study results were published in Journal of Clinical Oncology in May 2022.

Studies continue on tislelizumab. Data from the phase 3 trial RATIONALE 306 wer presented at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer. The trial showed that tislelizumab plus chemotherapy improved overall survival as a first-line treatment for esophageal squamous cell carcinoma regardless of PD-L1 status