Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended all development for non-small cell lung cancer (NSCLC).
Previous Development and Current Adjustments
In July 2022, Novartis previously scrapped plans to file for first-line monotherapy use of tislelizumab in NSCLC due to insufficient US-derived clinical trial data. However, development as a second-line combination therapy had continued. Now, the company has decided to halt further development in these areas in the US market.
Tislelizumab’s Global Development and FDA Review
Tislelizumab is being co-developed by Novartis in markets outside of China under a deal signed last year worth over USD 2 billion. The drug is currently under US FDA review as a second-line monotherapy for esophageal squamous cell carcinoma (ESCC). This review has faced delays due to the FDA’s inability to conduct onsite inspections. According to Novartis CEO Vas Narasimhan, the company expects to have sufficient US data for a filing of tislelizumab in combination with chemotherapy in the first-line ESCC setting. The Q3 2022 earnings report also indicated that a US FDA decision on tislelizumab as a second-line monotherapy for ESCC is still expected in H2 2022.-Fineline Info & Tech
