Now let's get Anktiva approved in Europe, and then a [global?] licensing deal....
FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage.
Excerpt from the PR (link below to complete version):
CULVER CITY, Calif., February 19, 2025 – ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a standard-of-care medicine in bladder cancer, to patients in the U.S.
Supply shortages of TICE® BCG in the U.S. have become a significant impediment to the treatment of bladder cancer patients. In a recent Sermo survey of 100 U.S. urologists, 57 percent indicated they were unable to treat patients in the last 12 months due to a lack of access to TICE® BCG.
The alternative BCG source has been developed by the Serum Institute of India, the world’s largest manufacturer of vaccines by volume. In bladder cancer clinical trials in Europe, the recombinant BCG vaccine has demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations.
“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,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “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.”
Link: FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage - ImmunityBio |
