Dive Brief:

• Novartis has terminated a global deal with BeiGene, retaining full rights back on the cancer immunotherapy tislelizumab, the China-based biotech said Tuesday. Also Tuesday, the European Commission announced it has approved the drug to treat a type of throat cancer.

• BeiGene said the Food and Drug Administration has begun reviewing tislelizumab, which will be marketed as Tevimbra, with a decision due in the second half of 2024. The FDA previously put off approving Tevimbra because it was unable to inspect Chinese facilities manufacturing the drug, due to travel restrictions related to the COVID-19 pandemic.

• This is the second time within the year Novartis has canceled a deal with BeiGene. In July, the Swiss drugmaker pulled the plug on a deal for another experimental BeiGene medicine called ociperlimab, which is in Phase 3 testing.

Dive Insight:

The deal’s cancelation leaves Novartis as one of the only big cancer drugmakers without an immunotherapy targeting PD-1, a checkpoint protein that helps the immune system target cancer cells. That protein is the target of similar drugs such as Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq.

Novartis signed with BeiGene for tislelizumab, or Tevimbra, in January 2021 for $650 million plus royalties in all the major markets outside China. The Swiss drugmaker followed up in December 2021 with the option deal for ociperlimab, to which it committed $300 million upfront and another $700 million if it exercised the option to acquire by the end of 2023.

Tevimbra’s European approval, and FDA review, is in a type of throat cancer called esophageal squamous cell carcinoma, in cases where it can’t be removed with surgery and has spread. It will be up against some entrenched competitors like Keytruda and Opdivo, which are used in combination with chemotherapy in the same setting. (Opdivo can also be used with another Bristol Myers immunotherapy, Yervoy.)

Both those drugs, along with Tecentriq, have a big headstart in many of the most common and difficult-to-treat cancers like melanoma and lung cancer, which could make it tough for Tevimbra to break in if it gets positive data. Tevimbra is approved in China, where BeiGene has sole rights, in lung cancer, lymphoma and other indications.

Novartis appeared to be getting ahead of the game when it partnered with BeiGene for ociperlimba, a different type of immunotherapy that targets the inhibitor TIGIT and could attack a broad range of tumors. However, drugmakers have grown less enthusiastic about TIGIT following some clinical disappointments, although a Roche project recently showed promise in lung cancer.

Following news of the deal’s termination, BeiGene struck a positive tone. “Tevimbra is the backbone of our diverse solid tumor development pipeline focused on developing novel combination regimens with precision medicine targets,” said Mark Lanasa, the company’s chief medical officer for solid tumors, in a statement.

When BeiGene released its second-quarter earnings in August, executives said they expected to ask the FDA and European Medicines Agency to approve Tevimbra for gastric cancer by the end of 2023.