
After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA
After a decade, a second CTLA-4 antibody may finally be on its way to approval.
AstraZeneca announced Monday that the FDA had given priority review to tremelimumab, its long-gestating CTLA-4 antibody, in combination with the PD-L1 inhibitor Imfinzi for patients with liver cancer that can’t be treated with surgery.
The Big Pharma’s application is based on a multi-year, 1,324-patient study that showed 30.7% of patients who received a “priming dose” of tremelimumab followed by Imfinzi were alive after three years, compared to 20.2% of patients who received Bayer’s sorafenib, the standard of care.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.