Pfizer Inc. (PFE - Free Report) and Japanese partner Astellas announced overall survival (OS) data from a late-stage study evaluating the combo of Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Data from the phase III PROSPER study showed that treatment with Xtandi plus ADT led to a statistically significant improvement in OS, a key secondary endpoint, in men with nmCRPC compared to placebo plus ADT.
Shares of Pfizer have declined 8.7% in the past year against the industry’s increase of 13.3%.
We remind investors that in July 2018, the FDA granted approval to Xtandi for treating the non-metastatic CRPC patient population based on metastasis-free survival (MFS) data from the PROSPER study. MFS was the first primary endpoint of the study while OS was its key secondary endpoint.
Meanwhile, in December 2019, the regulatory body approved Xtandi to treat men with metastatic castration-sensitive prostate cancer (mCSPC). The sNDA was based on data from the phase III ARCHES study.
Following this nod, Xtandi is now approved for three indications in advanced prostate cancer, namely non-metastatic and metastatic CRPC and mCSPC.
Notably, 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 worth $838 million in 2019, reflecting an increase of 20% year over year.
The label expansion of Xtandi allows it to treat a broader prostate cancer patient population and drive growth for Pfizer. However, the medicine faces competition from Johnson & Johnson’s (JNJ - Free Report) new prostate cancer drug Erleada and the generic versions of its product Zytiga.
Zacks Rank & Other Key Picks
Pfizer currently sports a Zacks Rank #1 (Strong Buy). Other stocks worth considering in the pharma/biotech sector include Novartis AG (NVS - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both carrying a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Novartis’ earnings estimates have moved 0.4% north for 2020 over the past 60 days. The stock has rallied 10.6% in the past year.
Vertex’s earnings estimates have been revised 13.5% upward for 2020 over the past 60 days. The stock has jumped 33.7% in the past year.
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