AstraZeneca has voluntarily withdrawn an indication for Imfinzi, its blockbuster PD-L1 checkpoint inhibitor.
Although the FDA gave the drug an accelerated approval nod for the indication in 2017, Imfinzi flopped a late-stage trial last year. According to the company, Imfinzi alone and in combination with tremelimumab, a CTLA4 inhibitor, failed to hit its goal of prolonging patients’ lives when compared to standard care.
After consulting further with the FDA, AstraZeneca made the call to withdrawal the drug from the bladder cancer space.
For now, Imfinzi’s is primarily used to treat patients with stage 3 non-small cell lung cancer, and the drug pulled in $2.4 billion in global revenue last year. But AstraZeneca is still testing the immunotherapy for several other indications including liver cancer, gastric cancer, cervical cancer and more.
Read the Reuters report.
