By Divya Grover
The drug, Xtandi, is already approved to treat metastatic castration-resistant prostate cancer (CRPC) - where the cancer has spread to other parts of the body - and raked in U.S. sales of $141 million in the second quarter for Pfizer.
An approval to treat non-metastatic CRPC would significantly boost sales of Xtandi, which Pfizer got access to when it bought Medivation for $14 billion last year. Astellas owns the rights to sell Xtandi outside the United States.
Pfizer said on Thursday that Xtandi, in combination with an anti-hormone therapy, was statistically significant in improving survival rate in men with non-metastatic CRPC without their cancer spreading, when compared with the standalone anti-hormone therapy.
Patients with CRPC experience cancer progression despite androgen deprivation therapy, a treatment that blocks the production of the hormone.
Earlier this month, the U.S. Food and Drug Administration approved Pfizer's Mylotarg for certain patients with acute myeloid leukemia, re-clearing a drug that had been pulled off the market in 2010.
Pfizer's shares rose 1.4 percent to $35.55 in light premarket trading.
(Reporting by Divya Grover and Tamara Mathias in Bengaluru; Editing by Savio D'Souza and Saumyadeb Chakrabarty)
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