FDA Accepts sBLA for Anktiva in Papillary-Only NMIBC

Summary: The FDA is reviewing a new use for the drug Anktiva. It treats a specific type of bladder cancer that doesn't get better with standard treatments. Right now, Anktiva is approved for one type of this cancer, but this new application is for patients with "papillary-only" disease, which affects even more people. In a recent study, patients taking Anktiva had great results. Over 92% of them avoided having their bladder removed after one year of treatment. The FDA will make its final decision by January 2027.

For more details, see rssapp-empr-com at empr.com/news/fda-accepts-sbla-anktiva-bcg-unresponsive-nmibc/ (opens in new tab)

Tags

Non-Muscle Invasive Bladder Neoplasms
Urinary Bladder Neoplasms
Disease
Neoplasms
Carcinoma
Bacillus
Mycobacterium bovis
Receptors, Interleukin-15
Interleukin-15