FDA AdCom Gives Thumbs Down To Late-Stage Data For Amgen's Lumakras In Advanced Form Of Lung Cancer (UPDATED)
Portfolio Pulse from Vandana Singh
FDA advisers have expressed doubts about the reliability of data from a late-stage trial of Amgen Inc's Lumakras for advanced lung cancer, voting 10 'no' to 2 'yes' for traditional approval. The drug had initially received FDA approval in 2021 through an accelerated pathway, contingent on confirmatory trial data. The confirmatory study data revealed that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34% compared to chemotherapy. A decision from the FDA on traditional approval is expected by December 24.
October 06, 2023 | 12:59 pm
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NEGATIVE IMPACT
FDA advisers have expressed doubts about the reliability of data from a late-stage trial of Amgen's Lumakras for advanced lung cancer. This could potentially impact the traditional approval of the drug.
The FDA advisers' doubts about the reliability of the trial data could potentially lead to a negative decision on the traditional approval of Lumakras. This could negatively impact Amgen's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
Mirati Therapeutics Inc's competitor, Krazati, could potentially benefit from the doubts expressed by FDA advisers about the reliability of data from a late-stage trial of Amgen's Lumakras for advanced lung cancer.
If the FDA decides against the traditional approval of Lumakras due to the doubts expressed by its advisers, this could potentially benefit Mirati's Krazati, a competitor in the same market. This could positively impact Mirati's stock in the short term.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 50