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Pfizer's Xtandi Label Expansion Filing Gets Priority Review

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Pfizer Inc. (PFE - Free Report) and its Japanese partner Astellas announced that the FDA has granted priority review to a supplemental new drug application (sNDA) for prostate cancer drug, Xtandi. Pfizer is looking to expand the label of Xtandi to include an early-stage patient population. With the FDA granting priority review, a decision is expected in July.

Pfizer also said that the European Medicines Agency (EMA) has validated a similar label expansion application in Europe.

Shares of Pfizer have returned 1.2% so far this year, almost in line with a 1.3% increase for the industry.

The regulatory applications to add the non-metastatic Castration-Resistant Prostate Cancer (“CRPC”) indication to the drug’s label were based on the results of thePROSPER study on Xtandi.

Detailed data from the phase III PROSPER study on Xtandi showed that treatment with the combination of Xtandi (enzalutamide) and androgen deprivation therapy (“ADT”) reduced the risk of metastases or death by 71% compared with ADT alone in men with non-metastatic CRPC.

In the double-blind study, the median metastasis-free survival (MFS) — the primary endpoint — was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone. We remind investors that top-line data from the PROSPER study was presented by Pfizer/Astellas in September 2017.

Many prostate cancer patients with non-metastatic CRPC — an earlier stage of prostate cancer — can experience disease progression despite ADT. However, presently no FDA approved treatment options are available to cater to this until these patients develop metastatic disease i.e. the cancer spreads to other parts of the body.

Xtandi is presently approved for the treatment of metastatic CRPC in patients who have previously received docetaxel. If approved for the non-metastatic patient population, the label of Xtandi can be expanded to cover all patients with CRPC.

Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2017. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside the U.S. markets. Pfizer recorded Xtandi alliance revenues of $590 million in 2017.

Zacks Rank & Other Stocks to Consider

Pfizer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

Some other large-cap pharma stocks worth considering are H. Lundbeck , Glaxo (GSK - Free Report) and Roche (RHHBY - Free Report) , all with the same Zacks Rank as Pfizer.

Shares of H. Lundbeck  have returned 12.9% this year so far. Estimates for 2018 have increased 8.5% over the past 60 days.

Glaxo’s shares are up 5.8% this year so far. Over the past 60 days, earnings estimates have risen 5.4% and 3.5%, respectively, for 2018 and 2019.

Over the past 60 days, Roche’s earnings estimates have risen 2.4% and 0.4%, respectively, for 2018 and 2019.

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