FDA Approves Anktiva Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
ImmunityBio, Inc. has announced that the FDA has approved Anktiva plus Bacillus CalmetteGuérin (BCG) for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
- Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).
- Bladder cancer is the 10th most commonly diagnosed cancer globally, and in the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.
- With the approval of Anktiva in combination with BCG, NMIBC, patients who would otherwise face highly invasive surgery with life long consequences have an important new therapeutic option with a long-term durable complete response.
Source: ImmunityBio, Inc.
