Mirati’s lung cancer drug gets EU’s regulatory backing

European Medicines Agency

Mirati’s lung cancer drug gets EU’s regulatory backing

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

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Source: Reuters