Pfizer Says EU Regulators Recommend Talzenna be Given Marketing Authorization
April 26 2019 - 12:05PM
Dow Jones News
By Stephen Nakrosis
Pfizer Inc. (PFE) on Friday said European Union regulators
recommended its Talzenna be granted marketing authorization in the
EU.
The company said the positive opinion was issued by the
Committee for Medicinal Products for Human Use of the European
Medicines Agency.
The indication adopted is for the use of Talzenna to treat
certain adult breast cancer patients.
Pfizer said the positive opinion was "based on results from
largest Phase 3 trial performed to date of a PARP inhibitor in
gBRCA-mutated advanced breast cancer."
The committee's opinion will now be reviewed by the European
Commission, Pfizer said.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 26, 2019 11:50 ET (15:50 GMT)
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