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Pfizer's Xtandi Gets FDA Nod for Expanded Patient Population

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Pfizer's Xtandi Gets FDA Nod for Expanded Patient Population

FDA approves Pfizer's (PFE) sNDA to expand the label of Xtandi to include the non-metastatic prostate cancer patient population.

Pfizer Inc. PFE and its Japanese partner Astellas announced that the FDA has granted approval to a supplemental new drug application (sNDA) for prostate cancer drug, Xtandi. With the latest approval, the label of Xtandi has been expanded to include an early-stage patient population - non-metastatic castration-resistant prostate cancer (“CRPC”).  In March, the sNDA was granted priority review designation by the FDA.

Shares of Pfizer have returned 3.6% so far this year against a 1% decrease for the industry.



The regulatory application to add the non-metastatic CRPC indication to the drug’s label was based on the results of the PROSPER 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, until now, no FDA approved treatment options were available to cater to this until these patients develop metastatic disease i.e. the cancer spreads to other parts of the body.

Xtandi was until now approved for the treatment of metastatic CRPC in patients who have previously received docetaxel. With approval for the non-metastatic patient population, the label of Xtandi now covers all patients with CRPC, metastatic as well as non-metastatic.

Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. 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 $159 million in the first quarter of 2018.

Zacks Rank & Stocks to Consider

Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

Some better-ranked large pharma/biotech stocks include H. Lundbeck HLUYY, Alexion, Inc. ALXN and Amgen, Inc. AMGN. While Lundbeck sports a Zacks Rank #1 (Strong Buy), Alexion and Amgen have a Zacks Rank #2 (Buy).

Amgen’s shares have gained 12.7% this year so far. Over the past 60 days, earnings estimates have risen 0.3% and 0.2%, respectively, for 2018 and 2019.

Alexion’s shares have risen 13.6% this year so far.

Shares of H. Lundbeck have returned 36.7% this year so far.

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