BeiGene will need to wait a bit longer for an FDA decision on cancer immunotherapy, Tevimbra, citing a delay in scheduling clinical site inspections.
The disclosure, included in BeiGene’s second-quarter earnings release Wednesday, temporarily halts the expansion of the drug’s label to first-line unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma. The company did not provide an updated timeline in its earnings announcement.
The drug already nabbed FDA approval in March for advanced or metastatic ESCC who previously tried chemotherapy. The company is only a few weeks into its US launch of Tevimbra after the treatment became available in the second half of this year.
In September of last year, BeiGene was given back the global commercial rights to the drug after Novartis backed out, ending a two-year collaboration. Back in January 2021, Novartis paid $650 million for global commercial rights to Tevimbra.
The drug has faced regulatory delays before. The Covid-19 pandemic pushed back the FDA’s inspection of BeiGene’s site and subsequently its first decision. The site was finally assessed two months before Novartis handed back the rights to BeiGene.
More than just delays, Novartis realized that it didn’t want to compete in the crowded PD-1 space, where Merck’s Keytruda and Bristol Myers Squibb’s Opdivo dominate. CEO Vas Narasimhan confessed on the company’s second-quarter earnings call in July that its approach to competing in the metabolic market was informed by previous investments in cancer immunotherapy.
“We had the experience of coming late into PD-1 inhibitors and immuno-oncology with lots of capital spent,” he said on July 18. “In the end, probably not well-spent.”
Mark LanasaBeiGene feels differently. The drug is in at least 17 registrational studies, according to Mark Lanasa, its chief medical officer for solid tumors, in March.
The company reported more than $537 million in Tevimbra sales in 2023 and $145 million in the first quarter of 2024, a 26% increase compared to the same period in 2023. That revenue came exclusively from ex-US markets, including China, where the drug is also approved to treat a form of liver cancer.
Several companies have snatched up rights to the drug at different times; Celgene was the first to sign on before it was later acquired by Bristol Myers, and then Novartis through the deal with BeiGene.