2022 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| YESCARTA axicabtagene ciloleucel |
To add a new indication for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. | 125643/394 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064 |
04/01/2022 |
| VONVENDI von Willebrand factor (Recombinant) |
To update the US Prescribing Information to expand the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults diagnosed with severe Type 3 von Willebrand Disease receiving on-demand therapy | 125577/412 | Baxalta US Inc. 300 Shire Way Lexington, MA 02421 Lic. # 2020 |
01/28/2022 |