) recently announced that it has reached an agreement with the US
Food and Drug Administration (FDA) regarding label updates for
Faslodex (500 mg). Faslodex (500 mg) is indicated to treat
hormone receptor-positive metastatic breast cancer in
postmenopausal women suffering from disease progression after
Results along with a Kaplan-Meier plot of the final overall
survival (OS) analysis from a pivotal study (CONFIRM - COmparisoN
of Faslodex In Recurrent or Metastatic breast cancer) were
included in the drug's US Prescribing Information. The analysis
from CONFIRM showed that after at least 50 months follow-up
duration, an updated OS analysis was performed. A 4.1 month
difference in median OS was observed in Faslodex 500 mg versus
Faslodex 250 mg.
However, AstraZeneca said that the data from the study cannot
be considered statistically significant as no multiplicity
adjustments were made.
Faslodex (500 mg) also increased progression-free survival in
the CONFIRM study. AstraZeneca reported that risk was reduced to
an extent of 20% when compared to the 250 mg dose of the drug.
The label update for the drug also included information from an
additional two-year carcinogenesis study (in rats and mice). The
study had positive findings in both species.
We also remind investors that adverse events like
hypersensitivity reactions, including urticaria and angioedema
have been reported previously in association with the drug.
AstraZeneca recorded Faslodex sales of $167 million in the
third quarter this year, up 28% year over year.
However, we note that competition in the breast cancer market
is intense. Other players in the breast cancer market include
). We currently have a Neutral recommendation on AstraZeneca. The
stock carries a Zacks #3 Rank (Hold) in the short run.
ASTRAZENECA PLC (AZN): Free Stock Analysis
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