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FDA Updates AZN's Faslodex Label

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AstraZeneca (AZN) 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 antiestrogen therapy.

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 Roche Holding (RHHBY) and GlaxoSmithKline (GSK). We currently have a Neutral recommendation on AstraZeneca. The stock carries a Zacks #3 Rank (Hold) in the short run.

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