FDA Indefinitely Delays BeiGene/Novartis anti-PD-1 Esophageal Cancer Drug

Beigene_UpdatedLogo_CourtesyBeigene

Courtesy of Beigene

BeiGene and Novartis will have to wait a little longer for a potential regulatory review of their checkpoint inhibitor, tislelizumab, as a potential second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

Today, the two companies announced that the U.S. Food and Drug Administration has deferred action on the Biologics License Application for tislelizumab in this indication until inspections of facilities in China can be completed. The regulatory agency has been unable to inspect those sites due to COVID-19 related travel restrictions. 

In its announcement Thursday morning, BeiGene said the FDA only cited those travel restrictions as reasons for the delay. The regulator did not mention the need for additional safety and efficacy data in the letter. 

While the review of the BLA is deferred, BeiGene noted that the FDA did not provide a new anticipated PDUFA date. That suggests there could be some hope for a quick turnaround on potential approval if travel restrictions change. The initial PDUFA date was set for July 12. Beigene and Novartis will continue to work with the regulatory agency to support scheduling the required inspections as soon as possible.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, which Novartis licensed from BeiGene last year. For BeiGene, the checkpoint inhibitor is the first drug from its immuno-oncology biologics program. Marketing authorization applications for the anti-PD-1 drug have been accepted for potential approval in Europe for several indications, including as a first-line treatment for patients with locally advanced or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC), and as monotherapy following chemotherapy for locally advanced or metastatic NSCLC. It has also been approved as monotherapy, as well as a post-chemotherapy monotherapy for unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma.

John V. Oyler, co-founder, chairman and chief executive officer of BeiGene, said the companies are working to “facilitate the required inspections” in order to bring tislelizumab to patients with second-line esophageal cancer. ESCC is the sixth-leading cause of cancer globally. It is estimated that more than two-thirds of patients with this type of cancer have advanced or metastatic disease at the time of diagnosis, with an average five-year survival rate of only 5%.

Data supporting the BLA is based on results from the Phase III RATIONALE study that showed treatment with tislelizumab generated a 30% reduction in the risk of death and extended median overall survival by 3.5 months compared to chemotherapy in people with unresectable recurrent locally advanced or metastatic ESCC who had received prior systemic therapy. The overall survival data also showed a 46% reduction in the risk of death, the companies announced at the time. 

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