By Chris Wack
ImmunityBio shares advanced 17% to $3.34 after the company said the Food and Drug Administration awarded a regenerative medicine advanced therapy designation for Anktiva and CAR-NK for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy.
The immunotherapy company said the treatment is also for patients with multiply relapsed locally advanced or metastatic pancreatic cancer. The designation follows clinical data and significant overall survival correlations in multiple trials across multiple tumor types.
ImmunityBio said it intends to submit a Biologic License Application for the indication of reversal of lymphopenia in patients receiving standard-of-care chemotherapy and/or radiation and for the treatment of locally advanced or metastatic pancreatic cancer, which includes the first-in-class CAR-NK.
In the authorization letter, the FDA has committed to work closely with ImmunityBio to provide guidance and advice on generating the evidence needed to "support approval" of the indication above "in an efficient manner."
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 28, 2025 11:14 ET (16:14 GMT)
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