Mirati's lung cancer drug gets EU's regulatory backing
Nov 10, 2023 - reuters.com
Mirati Therapeutics has received a recommendation for approval from the European Medicines Agency's panel for its lung cancer treatment, Krazati. This comes after a re-examination of the drug, which had previously been declined for authorization in July. Krazati, which targets a mutated form of a gene found in about 13% of non-small cell lung cancers, has already received accelerated approval from the U.S. FDA and authorization from the UK health regulator.
The drug came back into the spotlight last month when the U.S. FDA's advisers declined to back a rival drug, Lumakras by Amgen, for traditional approval. Bristol Myers Squibb had agreed to buy Mirati for up to $5.8 billion earlier in October, aiming to diversify its oncology business with Krazati.
Key takeaways:
Mirati Therapeutics' treatment for a type of lung cancer has been recommended for approval by the European medicines regulator's panel.
The drug, Krazati, had previously been declined for authorization in July, but was backed after a re-examination.
Krazati targets a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers.
Bristol Myers Squibb had agreed to buy Mirati for up to $5.8 billion earlier in October, to diversify its oncology business with Krazati.
