Amgen Gets FDA Priority Review For Lung Cancer Treatment
14 December 2023 - 8:40AM
Dow Jones News
By Ben Glickman
Amgen has received priority review status from the Food and Drug
Administration for its biologics license application for a small
cell lung cancer treatment.
The Thousand Oaks, Calif.-based pharmaceutical company will get
an answer from the FDA on its application in six months, instead of
the typical 10 months.
Amgen's BLA is for tarlatamab, a treatment for advanced small
cell lung cancer with disease progression on or after
platinum-based chemotherapy.
The application is based on the results from a Phase 2
study.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
December 13, 2023 16:25 ET (21:25 GMT)
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