ImmunityBio Secures FDA Approval For Alternative BCG Supply

The U.S. Food and Drug Administration approved an expanded access program (EAP) from ImmunityBio Inc. to provide patients with an essential alternative BCG source which functions as a standard-of-care remedy for bladder cancer across the United States. Bladder cancer patients encounter severe treatment difficulties because TICE® BCG cannot be readily obtained in the United States marketplace. TICE® BCG supply shortage prevented 57% of U.S. urology specialists from performing treatments on patients during the previous year, according to the Sermo survey of 100 practitioners.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, said in a statement, “With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics. Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients.” 

Serum Institute of India operates as the world leader in vaccine manufacturing through its development of an alternative BCG source. The recombinant BCG vaccine shows strong immune effects on CD8+ and CD4+ T cells while ensuring better safety results during bladder cancer trials conducted across Europe.