FDA Approves Nogapendekin Alfa Inbakicept Plus BCG for BCG-Unresponsive NMIBC
The FDA has approved nogapendekin alfa inbakicept-pmln (Anktiva; N-803) in combination with Bacillus Calmette–Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
The regulatory decision was supported by data from the phase 3 QUILT-3.032 trial (NCT0302285), which demonstrated that patients treated with the combination (n = 77) experienced a complete response (CR) rate of 62% (95% CI, 51%-73%). Additionally, 58% of patients who achieved a CR had a duration of response (DOR) of at least 12 months, and 40% of patients with a CR had a DOR of at least 24 months.
In May 2023, the FDA issued a complete response letter to the initial biologics license application (BLA) for N-803. In the letter, the regulatory agency cited deficiencies related to the pre-license inspection of ImmunityBio’s third-party contract manufacturing organizations as the reason the application could not be approved in its prior form. The BLA was resubmitted in October 2023.
April 24, 2024
