FDA Accepts Biologics License Application for Tislelizumab for Esophageal Cancer

Clinical trial results found a 30% reduction in the risk of death and a 2.3-month extension in median overall survival among patients with advanced or metastatic esophageal squamous cell carcinoma treated with tislelizumab.

The FDA has accepted a Biologics License Application (BLA) for the anti-programmed cell death protein-1 (anti-PD-1) antibody tislelizumab for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who received prior systemic therapy.

The BLA is supported by data from the phase 3 RATIONALE 302 trial, which found a 30% reduction in the risk of death and a 2.3-month extension in median overall survival compared to patients receiving chemotherapy. The drug is a humanized immunoglobulin-G4 anti-PD-1 monoclonal antibody that is being developed for use both as a monotherapy and in combination with other therapies.

“This is an encouraging step forward in our mission to deliver transformative therapies for people living with cancer, and especially for people with esophageal cancer, an aggressive disease with limited treatment options,” said Jeff Legos, executive vice president and global head of oncology and hematology development at Novartis, in a press release. “We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy.”

ESCC is the most common type of esophageal cancer globally and is the sixth leading cause of cancer-related deaths. According to the press release, there are approximately 17,000 people living with the disease in the United States and there will be an estimated 19,000 new cases diagnosed. More than two-thirds of patients with ESCC have advanced or metastatic disease at the time of diagnosis and the 5-year survival rate for metastatic disease is just 5.2%.

“We will work with regulatory authorities to ensure it is available for people with esophageal cancer as soon as possible,” Legos said in the press release.

REFERENCE

Novartis announces first FDA filing acceptance for anti-PD-1 antibody tislelizumab for people with esophageal cancer. News release. Novartis; September 13, 2021. Accessed September 16, 2021. https://www.novartis.com/news/media-releases/novartis-announces-first-fda-filing-acceptance-anti-pd-1-antibody-tislelizumab-people-esophageal-cancer