FDA Approves Tevimbra for Advanced Esophageal Cancer at $15,828 Per Month

BeiGene’s Tevimbra (tislelizumab-jsgr) recently received FDA approval for use in combination with platinum-containing chemotherapy as a first-line treatment for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 proteins.

Esophageal squamous cell carcinoma is a subtype of esophageal cancer that originates in the thin, flat cells lining the esophagus. It's most commonly found in the upper and middle regions of the esophagus but can occur anywhere along the esophageal tract.

When cancer spreads to other parts of the body, it's known as metastasis. If the cancer has advanced beyond the point of surgical removal, it's unresectable. Generally, esophageal cancers in stages 0, 1 and 2 are considered potentially resectable.

Esophageal cancer is one of the most lethal cancers globally, ranking as the sixth leading cause of cancer-related mortality.

Esophageal squamous cell carcinoma accounts for approximately 90% of all esophageal cancer cases. Projections estimate that by 2040, there will be approximately 957,000 new cases of esophageal cancer worldwide, marking a nearly 60% increase from 2020, according to a news release by BeiGene.

Esophageal cancer. © cao - stock.adobe.com

In addition, more than two-thirds of patients present with advanced or metastatic disease at diagnosis, and those with distant metastases face a five-year survival rate of less than 6%.

This increase highlights the urgent need for innovative and effective treatment options.

The current standard treatment for unresectable esophageal squamous cell carcinoma is chemoradiotherapy, and for metastatic is a combination of platin/fluoropyrimidine-based systemic chemotherapy with checkpoint inhibitors.

According to BeiGene, Tevimbra is an injectable treatment designed to support the immune system in combating cancer by enhancing the immune system’s ability to recognize and attack tumor cells.

Initially launched in October 2024, Tevimbra has demonstrated potential across multiple tumor types and disease settings. The Tevimbra global clinical development program has enrolled nearly 14,000 patients across 66 trials in 34 countries and regions, the release said.

Currently, Tevimbra has received approval in more than 42 countries, and over 1.3 million patients have undergone treatment with the drug worldwide, according to the release.

The wholesale acquisition cost (WAC) of the therapy in the U.S. is currently set at $15,828 per month, according to a BeiGene spokesperson. However, the actual cost to providers may differ based on negotiated agreements between providers and pharmaceutical manufacturers.

This latest FDA approval is supported by findings from BeiGene’s RATIONALE-306 trial.

The randomized, placebo-controlled, double-blind, global Phase 3 trial evaluated the efficacy and safety of Tevimbra in combination with platinum-based chemotherapy as a first-line treatment for over 600 adult patients with unresectable and metastatic esophageal squamous cell carcinoma.

A significant improvement in overall survival for patients receiving Tevimbra, including chemotherapy, compared to those receiving placebo and chemotherapy was found.

Among the 481 patients within the PD-L1 group, the median overall survival was 16.8 months for patients treated with Tevimbra and chemotherapy, compared to 9.6 months for those receiving placebo and chemotherapy. These findings resulted in a 34% reduction in the risk of death.

Mark Lanasa, M.D., Ph.D., chief medical officer of solid tumors at BeiGene, said in the news release that this is the organization's third FDA approval within a year for the new therapy.

Previous approvals include Tevimbra’s authorization for gastric cancer in December 2024 and its initial approval for treating advanced or metastatic esophageal squamous cell carcinoma following prior chemotherapy in March 2024.

“FDA approval of Tevimbra for the first-line treatment of advanced esophageal squamous cell carcinoma marks a significant step forward in tackling the unmet needs in this challenging disease area,” Lanasa stated.