US FDA turns down full approval of Amgen lung cancer drug Lumakras
New Delhi: The U.S. health regulator on Tuesday declined to grant traditional approval to Amgen's Lumakras for treating lung cancer patients with a specific gene mutation, although it kept the drug's existing accelerated approval status.
The U.S. Food and Drug Administration (FDA) now requires data from an additional confirmatory study to support the drug's full approval, which will be completed no later than February 2028, the company said.
Lumakras was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data as a condition for gaining traditional approval.
The company has said its older confirmatory study shows that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34 per cent, compared with chemotherapy, but there was no significant difference in overall survival.
An FDA advisory committee in October voted 10 to two that the main goal of that late-stage study could not be relied upon to assess the drug's benefits.
Much of the committee's discussion had centered on concerns that trial investigators allowed too many patients to switch between the treatment and control arms of the study.
Lumakras is an oral drug designed to target a mutated form of a gene known as KRAS that occurs in about 13 per cent of non-small cell lung cancers, the most common type of lung cancer, and less frequently in some other solid tumors.
A similar drug, Krazati from Mirati Therapeutics , received accelerated FDA approval late last year, also for patients with advanced lung cancer who test positive for the KRAS mutation. Mirati is being acquired by Bristol Myers Squibb.
Amgen's sales of Lumakras totaled $199 million in the first nine months of this year, down from $214 million in the same 2022 period.
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