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Pfizer/Astellas Xtandi Gets Nod in China for Prostate Cancer (Revised)

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Pfizer, Inc.’s (PFE - Free Report) partner Astellas announced that the Chinese regulatory authority has approved their cancer drug Xtandi.

The drug was approved by China National Medical Products Administration (NMPA) on Nov 18 to treat men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic and had disease progression despite androgen deprivation therapy (ADT). The new drug application (NDA) seeking approval in China was based on data from an Asian multinational phase III study (Asian PREVAIL) involving Asian patients of which approximately 200 were Chinese. The efficacy and safety data from the study was consistent with the results from the pivotal global phase III PREVAIL study in the same patient population.

Pfizer’s shares have declined 12.9% this year so far against its industry’s 5.9% increase.


Xtandi is already approved to treat metastatic and non-metastatic castration-resistant prostate cancer in the United States. It is under review in the United States for metastatic hormone-sensitive prostate cancer (PDUFA date in December 2019).

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 drug’s marketing rights outside the U.S. markets. Pfizer recorded Xtandi-alliance revenues of $594 million in the first nine months of 2019.

Pfizer currently carries a Zacks Rank #2 (Buy). Other large-cap pharma stocks with the same Zacks Rank as Pfizer include Roche (RHHBY - Free Report) , Bristol-Myers (BMY - Free Report) and Merck (MRK - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Roche have gained 22.8% this year so far. Earnings estimates for 2019 have risen 1.2% while the same for 2020 increased almost 2% over the past 60 days.

Bristol Myers’ earnings estimates have increased 2.1% and 9.5%, respectively, for 2019 and 2020 over the past 60 days. The stock has rallied 11% this year.

Merck’s stock is up 14.3% this year so far. Its earnings estimates have risen almost 4.9% for 2019 and 2% for 2020 over the past 60 days.

(We are reissuing this article to correct a mistake. The original article, issued on Nov 27, 2019, should no longer be relied upon.)