AstraZeneca Says Faslodex Superior to Arimidex in Breast Cancer Treatment Trial
May 27 2016 - 2:58AM
Dow Jones News
By Razak Musah Baba
LONDON--AstraZeneca PLC (AZN.LN) said Friday it had positive
results from the Phase III hormonal therapy trial comparing the
Faslodex drug to Arimidex in the treatment of breast cancer.
The biopharmaceutical firm said the trial compared Faslodex 500
milligrams with Arimidex 1 milligram for the treatment of
locally-advanced or metastatic breast cancer in post-menopausal
women who haven't had prior hormonal treatment for
hormone-receptor-positive breast cancer.
AstraZeneca said Faslodex was superior to Arimidex and met its
primary endpoint of extended progression-free survival.
Aromatase inhibitors such as Arimidex are the current standard
of care in first-line treatment for postmenopausal women with
advanced HR+ breast cancer.
"The FALCON results bring us closer to offering more and earlier
treatment options to postmenopausal women with HR+ locally-advanced
or metastatic breast cancer; the potential to delay disease
progression is important for these patients as there is currently
no cure. Faslodex has over 10 years of clinical evidence and we are
committed to exploring its potential along with the rest of our
outstanding oncology portfolio," said Sean Bohen, Executive Vice
President, Global Medicines Development and Chief Medical Officer
at AstraZeneca.
Also Friday, AstraZeneca announced that the U.S. Food and Drug
Administration has issued a Complete Response Letter or CRL
regarding the New Drug Application for sodium zirconium
cyclosilicate (ZS-9), the investigational medicine being developed
for the treatment of hyperkalaemia, a high potassium level in the
blood serum, by ZS Pharma, a subsidiary of AstraZeneca.
The CRL refers to observations arising from a pre-approval
manufacturing inspection. AstraZeneca and ZS Pharma are evaluating
the content of the CRL and will work closely with the FDA to
determine the appropriate next steps for the New Drug Application,
the company said.
-Write to Razak Musah Baba at razak.baba@wsj.com; Twitter:
@Raztweet
(END) Dow Jones Newswires
May 27, 2016 02:43 ET (06:43 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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