nogapendekin alfa inbakicept-pmln (Anktiva): FDA status

Approved Approved Apr 22, 2024. Indication: BCG unresponsive NMIBC with carcinoma in situ with or without papillary tumors. Company: ImmunityBio.

Regulatory history

• Apr 22, 2024: Approved. FDA approved Anktiva, a first in class IL-15 agonist, for NMIBC ImmunityBio
• Oct 26, 2023: Decision date set. FDA accepted the BLA resubmission as a complete response to the CRL and set a new PDUFA date of April 23 2024. ImmunityBio press release
• Oct 26, 2023: FDA accepted for review. FDA accepted ImmunityBio's BLA resubmission for N-803 plus BCG as complete and set a new PDUFA date. drugs.com
• Oct 23, 2023: Application filed. ImmunityBio announced it completed resubmission of its BLA to FDA addressing issues raised in the May 2023 complete response letter. ImmunityBio press release

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