*.- Pfizer Presentó Dossier del Farmaco Ibrance para el Tratamiento del Cáncer de Mama a mediados de agosto del 2014 .
*.- La FDA le otorgo el Status de Revisión Prioritaría el 13 de Octubre del 2014 .
*.- Por lo que estaba previsto que la FDA daría su veredicto el 13 de Abril del 2015 .
*.- La sorpresa saltó el día 3 de Febrero del 2015 cuando la FDA anunció por sorpresa que Aprobaba el Ibrance con Dos meses de antelación al plazo previsto ... o sea a los Cuatro meses desde que le concedió el Status de Revisión Prioritaría .
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Pfizer Receives FDA Approval For Breast Cancer Drug Ibrance Two Months Early .
2/3/2015 // RTT .
Pharma giant Pfizer, Inc. (PFE: Quote) announced late Tuesday that the U.S. Food and Drug Administration or FDA, has granted accelerated approval of Ibrance (palbociclib), in combination with letrozole, as first-line systemic treatment for advanced or metastatic breast cancer in post-menopausal women.
This will be the first medicine in a new class of anti-cancer agents, cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors, to be approved by the FDA.
The FDA approved the breast cancer drug Ibrance more than two months ahead of the scheduled Prescription Drug User Fee Act (PDUFA) goal date of April 13, 2015.
"Today's FDA approval of IBRANCE marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need, and underscores the contributions our company can make to society," Chairman and CEO Ian Read said in a statement.
Pfizer submitted the New Drug Application or NDA, to the FDA in mid-August and it was granted Priority Review by the FDA on October 13, 2014. The drug received Breakthrough Therapy designation from the FDA in April 2013.
The FDA's Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
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