REUTERS/Dado Ruvic/Illustration/File photo Acquire Licensing RightsOct 3 (Reuters) - The U.S. Food and Drug Administration staff reviewers said on Tuesday Amgen's (AMGN.O) late-stage study might not be sufficient to confirm the effectiveness for its lung cancer drug, as the firm pursues a traditional nod for the treatment.
Amgen's drug was granted accelerated approval by the U.S. FDA in 2021 for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines.
The U.S. health regulator grants the so-called accelerated approval based on data that show therapies are likely to work, and requires confirmatory trials later to give them traditional approval.
Data from the study showed Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34%, compared with chemotherapy in a clinical trial.
The agency is expected to make a decision on traditional approval for the drug by Dec. 24.
Persons:
Dado Ruvic, Amgen's, William Blair, Matt Phipps, Lumakras, Bhanvi Satija, Shounak Dasgupta, Sherry Jacob, Phillips
Organizations:
REUTERS, U.S . Food, Drug Administration, U.S, FDA, Thomson
Locations:
U.S, Bengaluru