FDA Accepts BeiGene’s BLA for Esophageal Cancer Drug

BeiGene and Novartis have announced the FDA acceptance of its biologics license application (BLA) review for tislelizumab in patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) and have received at least one line of chemotherapy.

This January, Novartis purchased from BeiGene the rights to develop and commercialize tislelizumab in major markets outside of China, which included the US, Europe, and Japan. The deal included a $650 million upfront payment and $1.55 billion in milestones.

Tislelizumab is an anti-PD1 monoclonal antibody that inhibits immune checkpoints, allowing T cells to destroy cancer cells. This is the Beijing-based company’s second internally developed medicine filed outside China. Its blood cancer drug Brukinsa has already obtained FDA approval for several indications.

Rationale 302 Results as Basis for FDA Filing

The accepted BLA, filed in collaboration with Novartis, is backed up by positive data from the Phase 3 Rationale 302 study. The multicenter, global Phase 3 trial supported the efficacy and safety of tislelizumab as a treatment for patients with advanced or metastatic ESCC. 

In the trial, tislelizumab was shown to cut the risk of death by 30% and extend median overall survival by 2.3 months compared to second-line chemotherapy. The drug also had a favorable safety profile compared to the second-line chemotherapy, with no new safety signals detected. The study results were presented at the 2021 American Society of Oncology Annual Meeting (ASCO 2021).

The BLA submission also included safety data on 1972 patients who received tislelizumab as monotherapy from seven clinical trials. The FDA review has an action date of 12th July next year. 

Demand in China

“Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there. We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world,” said Yong Ben, M.D., the Chief Medical Officer at BeiGene.

Tislelizumab is approved in China as a treatment for classical Hodgkin lymphoma, PD-L1-high urothelial carcinoma, non-small cell lung cancer (NSCLC), and liver cancer hepatocellular carcinoma (HCC). The steady rate at which the drug gains approval in China puts it in a good position to accumulate FDA approvals to treat multiple cancers.

This could put BeiGene’s drug in direct competition with other drugs that operate via anti-PD1 inhibition, such as Bristol-Myers Squibbs’ Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab). An expanded list of approved indications boosted tislelizumab sales in China to $74.9 million in the second quarter of 2021, up from $29.4 million in the year prior.

Author

Joy Lin

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