Novartis, BeiGene cancer drug faces delay as FDA puts off approval decision

Dive Brief:

• The Food and Drug Administration has put off deciding whether to approve a cancer drug from Chinese biotech company BeiGene and partner Novartis, deferring any action on the companies’ application until it can complete inspections of BeiGene’s facilities in China. 
• In a statement Thursday, BeiGene said the FDA was unable to inspect its sites in time due to travel restrictions related to COVID-19, an issue that has come up before with other approval applications that have come before the agency over the past two and a half years. 
• According to BeiGene, the FDA did not cite any other reasons for deferring its decision, suggesting the agency doesn’t have issues with the safety and efficacy profile of the drug, called tislelizumab. The FDA hasn’t provided a new decision date, however, putting the application in regulatory limbo. 

Dive Insight:

An immunotherapy and potential competitor to top-selling drugs from Merck & Co., Bristol Myers Squibb and Roche, tislelizumab is an important product for both BeiGene and Novartis. 

Last year, Novartis paid BeiGene $650 million for partial rights to tislelizumab in major markets outside of China, citing its potential as a monotherapy and in combination with other cancer medicines. The drug works by blocking a protein known as PD-1, thereby helping immune cells recognize and destroy cancers. Drugs that do this, such as Merck’s Keytruda and Bristol Myers’ Opdivo, have become widely used across a large number of tumor types. 

Despite a research focus on oncology, Novartis still lacks an approved PD-1 inhibitor, nearly a decade after Keytruda and Opdivo were first approved. The BeiGene deal was done to address that gap, so the decision deferral by the FDA represents a setback for Novartis. 

The application in question was for approval of tislelizumab in a type of throat cancer that had either spread or was unable to be removed through surgery. Results from a Phase 3 study conducted in Europe, the U.S. and Asia showed treatment reduced the risk of death by 30% versus chemotherapy, extending the median time study participants lived by two months. The FDA had scheduled a decision date of July 12.

The FDA has scrutinized cancer drug approval applications from Chinese companies more closely in recent months, citing concerns with single-country clinical trials. In March, the agency rejected a cancer immunotherapy from Innovent Biologics and Eli Lilly, and then in May turned back applications from Hong Kong-based Hutchmed and partners Junshi Biosciences and Coherus BioSciences. 

In announcing the rejection, Junshi and Coherus also cited difficulties related to COVID-19 travel restrictions and FDA inspections. 

“We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the U.S. following regulatory approval,” said BeiGene CEO John Oyler in a statement. 

In China, tislelizumab is already approved to treat Hodgkin lymphoma, as well as certain lung and bladder cancers. China’s drug regulator in April approved the medicine for the same indication in second-line esophageal squamous cell carcinoma that BeiGene and Novartis are asking the FDA’s clearance for. 

For Novartis, the delay is the second time the pandemic has affected the review of one of its high-profile experimental drugs. In December 2020, the FDA rejected a cholesterol therapy from the Swiss pharma after being unable to inspect the company’s facility in Italy where it manufactured the drug. Novartis eventually won FDA approval of the therapy, now called Leqvio, one year later. 

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