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Day Staff Writer
Pfizer Inc. said Monday it has completed its new drug application for the breast-cancer remedy palbociclib, which earned breakthrough status last year from federal regulators when used in conjunction with another medicine, letrozole.
The U.S. Food and Drug Administration has 60 days to review the filing to determine whether it is complete. The agency will then review the drug for safety and effectiveness before determining whether it should be approved for public use.
"Today's submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer," said Garry Nicholson, Pfizer oncology research division presdient.
Pfizer's drug-development work is headquartered in Groton, where about 3,000 scientists work.
Pfizer reported in April 2013 that the FDA granted palpociclib breakthrough status based on early studies showing that the drug, in combination with letrozole, gave patients an average of about a year and a half of progression-free survival.
At the time, Leerink Swann analyst Seamus Fernandez declared that the drug could worth $2.4 billion.
The drug combination has been targeted for postmenopausal women with with advanced breast cancer and specific genetic factors who have not received previous systemic treatment. Palbociclib helps block tumor growth, Pfizer said.
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