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 The company said a so-called label update to IRESSA meant a patient
could receive treatment with IRESSA after a blood test, instead of
having to provide a tumor sample.
The update will take effect immediately, AstraZeneca said. Usually,
recommendations for marketing approval by the Agency Committee for
Medicinal Products for Human Use (CHMP) are endorsed by the European
Commission within a couple of months.
"If doctors are unable to assess the mutation status of a tumor,
then patients' access to potentially life-changing medicines such as
IRESSA becomes restricted," AstraZeneca Chief Medical Officer Briggs
Morrison said in a statement.
"Today's decision by the CHMP to endorse a label update for IRESSA
is a significant step forward."
The recommendation is AstraZeneca's second in as many days. On
Thursday the European Medicines Agency recommended a combination
drug for chronic lung disease from Spain's Almirall, one of a number
of respiratory medicines being acquired by AstraZeneca.
[to top of second column] |
AstraZeneca signed a deal in July to buy Almirall's lung drugs to
build up its respiratory medicine business.
(Reporting by Sarah Young; editing by Jason Neely and Susan Thomas)
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