ImmunityBio has received FDA approval for its lead drug candidate, Anktiva, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval follows the successful completion of clinical trials that demonstrated a 62% complete response rate and a duration of response of over 47 months. Anktiva is the first-in-class IL-15 agonist immunotherapy to receive FDA approval for NMIBC and represents a significant milestone for ImmunityBio.
ImmunityBio’s Anktiva has received FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), marking a significant milestone for the company. The approval follows a successful trial, showing a 62% complete response rate and a 58% duration of response at 12 months. Anktiva enters a competitive market with existing treatments like Keytruda and Adstiladrin, and emerging therapies like TAR-200 and CG0070 showing promise. Despite the approval, ImmunityBio’s $3 billion enterprise value is seen as optimistic given the competitive landscape and financial challenges facing the company. Analysts anticipate sales of $84 million and $197 million in 2025 and 2026 respectively, but beyond that, Anktiva’s potential remains uncertain due to the upcoming fierce competition.
The FDA has approved ImmunityBio’s Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Anktiva, a first-in-class IL-15 agonist immunotherapy, received FDA Breakthrough Therapy Designation and approval based on its high complete response rate (62%) and long duration of complete response (over 47 months). The approval marks a significant milestone for ImmunityBio and the field of immunotherapy in bladder cancer treatment.
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