Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead.
The PD-1 inhibitor now carries the brand name Tevimbra. It’s approved to treat advanced esophageal squamous cell carcinoma after prior systemic chemotherapy, BeiGene said Thursday. Patients won’t be eligible for the drug if they have previously received a PD-1/L1 inhibitor.
The FDA was originally scheduled to deliver a verdict on the drug in July 2022, but COVID-related travel restrictions disrupted that plan because the agency wasn’t able to perform preapproval inspections in China. Tevimbra secured its initial approval in China in December 2019 for previously treated classical Hodgkin lymphoma.
Tevimbra isn’t the first PD-1 drug to reach esophageal cancer. Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo are both approved here.
BeiGene would have enjoyed Big Pharma commercialization support for Tevimbra from Novartis, but the two firms parted ways in September, with Novartis citing a changing PD-1 inhibitor landscape as its rationale. Novartis will still help manufacture Tevimbra.
Before the breakup, Novartis in 2022 decided not to file Tevimbra as a monotherapy for newly diagnosed non-small cell lung cancer (NSCLC) in the U.S. The decision came as the FDA cracked down on China-only data that didn’t reflect the treatment landscape in the U.S.
Amid BeiGene’s regulatory delay, Coherus BioSciences and Junshi Biosciences-partnered Loqtorzi became the first China-made PD-1 inhibitor to reach the U.S. market with two indications in nasopharyngeal carcinoma.
Tevimbra’s approval is based on the RATIONALE 302 trial, in which the BeiGene drug slashed the risk of death by 30% compared with chemotherapy. Patients on Tevimbra lived a median 8.6 months, versus 6.3 months for those who received traditional chemo.
The European Commission in September approved Tevimbra for the same post-chemo esophageal cancer indication.
BeiGene won’t launch Tevimbra immediately, saying it will make the drug available in the U.S. in the second half of 2024. The company also hasn’t launched the drug in Europe as it waits for a final European Commission approval for three NSCLC indications.
The FDA is reviewing another Tevimbra application in first-line esophageal cancer, with a decision expected in July. A BeiGene spokesperson declined to comment on whether the company is holding off the rollout until the first-line decision.
BeiGene will share Tevimbra’s price closer to launch, the spokesperson said. Coherus earlier this year launched Loqtorzi at a list price of $8,892.03 per single-use vial, which marks a 20% discount to Keytruda.
“As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the U.S., Tevimbra is poised to be a critical pillar of our solid tumor development program,” Mark Lanasa, M.D. Ph.D., BeiGene’s chief medical officer of solid tumors, said in a statement Thursday.
With multiple indications in China, Tevimbra grew sales by 27% year over year in 2023 to reach $537 million in 2023.