Mirati's lung cancer drug gets EU's regulatory backing (updated)

Mirati Therapeutics

10/11/2023 14:00

(Adds background on Mirati and its drug throughout)
       Nov 10 (Reuters) - Mirati Therapeutics  MRTX.O  said on
Friday the European medicines regulator's panel has recommended
approval of its treatment for a type of lung cancer.
    The European Medicine Agency's committee backed Krazati
following a re-examination of the drug the panel had declined to
back for authorization in July, saying the requirements for
conditional support were not fulfilled, which Mirati had
disagreed with.
    Krazati received the U.S. Food and Drug Administration's
accelerated approval last year and also the UK health
regulator's authorization earlier this month.
    The drug is designed to target 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.
    Earlier in October, Bristol Myers Squibb  BMY.N  had agreed
to buy Mirati for up to $5.8 billion, to diversify its oncology
business with Krazati.
    Krazati returned to spotlight last month after the U.S.
FDA's advisers declined to back a rival drug, Amgen's  AMGN.O 
Lumakras, for a traditional approval, saying that data from a
late-stage trial of the drug could not be relied upon.
        
    

 (Reporting by Christy Santhosh; Editing by Janane Venkatraman
and Shinjini Ganguli)
 ((Christy.Santhosh@thomsonreuters.com;))