(Reuters) – The U.S. Food and Drug Administration staff reviewers said on Tuesday Amgen’s 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.
The assessment comes ahead of a panel meeting of expert advisers to the U.S. health agency, who will vote on the reliability of the data on Thursday.
Lumakras, which bought in sales of $285 million last year, targets a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers – the most common form of the disease.
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.
Amgen’s late-stage confirmatory study may not be considered “adequate and well-controlled”, the staff reviewers said in briefing documents published on the FDA’s website, citing several issues with the way the study was conducted.
At least three analysts said the FDA panel could recommend an additional late-stage trial. “While the documents clearly read negative for Amgen … it does not suggest that Lumakras would need to be pulled from the market,” said William Blair analyst Matt Phipps.
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 U.S. health regulator usually follows the advice of its panel, but is not bound to do so. The agency is expected to make a decision on traditional approval for the drug by Dec. 24.
Shares of Amgen fell nearly 2% to $261.73.
(Reporting by Bhanvi Satija and Pratik Jain in Bengaluru; Editing by Shounak Dasgupta and Sherry Jacob-Phillips)
Source link : https://www.medscape.com/s/viewarticle/997039?src=rss
Publish date : 2023-10-04 13:42:15
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