FDA has granted Altor BioScience, LLC approval for nogapendekin alfa inbakicept-pmln (Anktiva) for use with Bacillus Calmette-Guerin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
This approval signified a significant step forward for patients with BCG-unresponsive NMIBC based on the positive results of QUILT-3.032 for nogapendekin alfa inbakicept-pmln.
The Assessment Aid supported the review process for this therapy, emphasizing the FDA’s commitment to working collaboratively with drug developers to bring new treatments to patients with NMIBC.
The FDA acknowledged the potential of nogapendekin alfa inbakicept-pmln by granting the application a breakthrough designation.
Noga pendekin alfa inbakicept-pmln is reserved for therapies that have the potential to be a significant improvement over existing options for NMIBC.
The FDA emphasized the importance of reporting any severe side effects related to nogapendekin alfa inbakicept-plmn for NMIBC through the MedWatch Reporting System.
Healthcare professionals seeking assistance with single-patient investigational use of the drug for oncology patients can reach out to OCE’s Project Facilitate.
Source: FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer
