BeiGene is relatively new to immuno-oncology, and the China-based company’s efforts to bring its first drug of its kind to the U.S. market will take a while longer. FDA decision on BeiGene’s esophageal cancer drug has Delay Until the agency can complete inspections of immunotherapy manufacturing facilities.
The drug, tislelizumab, has been commercialized in China. A regulatory decision in the U.S. is due on Tuesday. According to BeiGene, the FDA cited Covid-19 travel restrictions as a reason for not being able to complete required inspections — an increasingly common problem during the pandemic. BeiGene, which aims to work with Novartis to commercialize tislelizumab in the U.S. and other markets, said its drug is still under FDA review, but the agency has yet to provide a new decision date.
“BeiGene and Novartis will continue to work actively with the FDA to support scheduling the required inspections as quickly as possible,” the company said in Thursday’s delayed announcement.
Tislelizumab belongs to a class of anticancer drugs called checkpoint inhibitors. The antibody drug is designed to block PD-1, a protein on T cells that prevents them from recognizing tumors. Blocking this protein allows immune cells to detect and fight cancer cells. BeiGene has been seeking approval of tislelizumab as a second-line treatment for patients with advanced esophageal squamous cell carcinoma. In phase 3 testing, the results showed a 30 percent reduction in the risk of death. Compared with chemotherapy, tislelizumab treatment extended overall survival by a median of 2.3 months. If the BeiGene drug wins FDA approval, it would compete with Merck & Co’s Keytruda and Bristol-Myers Squibb’s Opdivo, checkpoint inhibitors already approved in a variety of cancers, including esophageal cancer.
The delayed decision on tislelizumab is also a setback for Novartis, which has rights to the drug in North America, Europe, Russia and Japan. The Swiss pharma giant paid BeiGene $650 million upfront in early 2021 get These rights and began to forge partnerships on drugs, including clinical trials testing immunotherapy in combination with other cancer treatments. The transaction qualifies BeiGene to receive up to $1.3 billion in regulatory milestone payments and $250 million in sales-based milestone payments.
last year end, BeiGene and Novartis expand their relationship with a new agreement covering another drug, ociperlimab. This antibody drug targets a different checkpoint protein called TIGIT. Novartis paid BeiGene up to $300 million to begin the partnership. The deal requires the Swiss pharma giant to pay an additional $700 million when it exercises its option to license ociperlimab.
FDA public domain photo
