Monday, the FDA approved ImmunityBio Inc’s IBRX Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
The drug is combined with the BCG vaccine, mainly used against tuberculosis and as a common treatment for some forms of bladder cancer.
Last year in May, the FDA issued a complete response letter to Anktiva plus BCG treatment, citing deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations.
“The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.
The company says Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received FDA Breakthrough Therapy Designation and approval based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).
The CR rate for the 77 evaluable patients was 62%, with the upper end of the confidence interval being 73%.
The duration of the complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date.
The company adds that the prolonged duration of complete response results beyond 24 months with ANKTIVA and BCG exceeds the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the IBCG.
The duration of response is ongoing, so the final median duration of response has yet to be determined. 58% of patients with CR had a DOR ≥ 12 months, and 40% had a DOR ≥ 24 months.
Anktiva is expected to be available in the U.S. by mid-May 2024.
Price Action: IBRX shares are up 4.65% at $5.17 at the last check Tuesday.
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