Business
ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe
ANKTIVA plus BCG is the first immunotherapy for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nANKTIVA plus BCG is the first immunotherapy for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to receive a positive recommendation for marketing authorization in Europe. For patients whose disease does not respond to BCG, there are currently no authorized treatment options; the primary option is surgical removal of the bladder.\n\n\nUnlike the U.S., where only one BCG substrain is approved, Europe recognizes and has approved approximately six major BCG substrains, making standard-of-care therapy broadly available across the region.1\n\n\nThe recommendation is based on the EMA’s determination that the benefit of making ANKTIVA available to patients now outweighs the risks associated with earlier access, providing an important option for adults with BCG-unresponsive NMIBC, and builds on existing approvals in the U.S. and United Kingdom.\n\n\nEach year, more than 150,000 people in Europe are diagnosed with NMIBC.2\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. This recommendation will help facilitate early access to medicines that address conditions where the remaining treatment option is surgery to remove the bladder.\n\n“ANKTIVA represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Hundreds of patients in the U.S. are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy. We are pleased that the EMA issued this positive recommendation based on our single-arm trial and through a regulatory process that allows earlier access to ANKTIVA, when as stated in the EMA announcement, the benefit of a medicine’s immediate availability to...