The U.S. FDA has rejected ImmunityBio's marketing application for its combination therapy for a type of bladder cancer.
San Diego-based ImmunityBio received a complete response letter from the agency on May 9 regarding its Biologics License Application for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.
The drugmaker said the FDA flagged deficiencies related to its inspection of the company's third-party contract manufacturing organizations. The agency also provided recommendations regarding additional chemistry, manufacturing and controls issues and assays to be resolved.
Anktiva — ImmunityBio’s lead cytokine fusion protein — is a novel IL-15 superagonist complex. It received Breakthrough Therapy and Fast Track designations. The agency's recent decision came ahead of the drug's May 23 PDUFA date.
According to ImmunityBio, the FDA didn't request any new preclinical studies or phase 3 clinical trials. The drugmaker plans to meet with the agency as soon as possible to address the issues and establish a response timeline.
