AstraZeneca's Brilinta Gets US Approval; EU Recommends Lynparza
By Anthony O. Goriainoff
AstraZeneca PLC said Monday that Brilinta has been approved in
the U.S. to reduce the risk of a first heart attack or stroke, and
that Lynparza has been recommended for marketing authorization in
the EU for patients with metastatic pancreatic cancer.
The U.K. drug maker said the U.S. Food and Drug Administration
based its approval on positive results from the phase III THEMIS
The pharmaceutical company also said the EU marketing
authorization is for the first line treatment of patients with
germline BRCA-mutated metastatic pancreatic cancer. The European
Medicines Agency based its decision on results from the phase III
POLO trial which showed Lynparza nearly doubled the time patients
with germline BRCA-mutated metastatic pancreatic cancer lived
without disease progression to a median of 7.4 months, versus 3.8
months for those on a placebo.
Write to Anthony O. Goriainoff at
(END) Dow Jones Newswires
June 01, 2020 02:43 ET (06:43 GMT)
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