Pfizer Receives FDA Approval For Breast Cancer Drug Ibrance Two Months Early .
Pues hace escasamente un mes la FDA Aporobaba el Farmaco Ibrance ( Pfizer ) para el Tratamiento de Cáncer de Mama ... a los Cuatro meses de Haber obtenido el Status de " Revisión Prioritaria " por parte de la FDA :
*.- 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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BERLIN, Germany I March 5, 2015 .
Bayer HealthCare today announced that it is suspending enrolment into a Phase III trial with regorafenib (Stivarga®) in colorectal cancer patients with resected liver metastases due to insufficient patient recruitment. The randomized, double-blind, placebo-controlled Phase III trial is evaluating regorafenib as an adjuvant treatment of colorectal cancer following resection of liver metastases with curative intent. As a result of slow patient accrual, the study will be closed to further enrolment before the study endpoints can be assessed. Importantly, there were no new safety signals from the study.
“We are disappointed that the extensive measures to increase recruitment did not have the desired outcome. We would like to thank the patients and the study investigators for their contributions and participation in this study,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Importantly, this decision does not affect our commitment for Stivarga in the approved as well as potential additional indications. We will continue to evaluate regorafenib in a number of tumor types with significant unmet medical needs, including colorectal cancer.”Bayer is informing Health Authorities and investigators on the planned enrolment suspension.
The company is actively working with the Data Monitoring Committee, the Study Steering Committee and investigators with regard to the appropriate disposition of patients who have entered into the trial. A summary of the findings will be disclosed to the public as available.
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López Vivanco, jefe de oncología del Hospital de Cruces, es una autoridad del cáncer. Treinta años de oficio le ayudan a descifrar el mundo de los tumores
Bilbao - ¿Cuál es el cáncer más rebelde, el más traicionero?
-No te puedes fiar de ningún tumor, todos los cánceres son traicioneros. Pero hay algunos que tienen mala supervivencia porque se diagnostican en fases avanzadas, ya que al principio no dan muchos síntomas. Es el caso del carcinoma de páncreas.
¿Y el más fácil? ¿El más predecible?
-Los más predecibles son los que dan síntomas más tempranos y los que se asientan sobre zonas fáciles de visualizar. Los de cavidad oral, los melanomas o tumores cutáneos malignos. También entraría en ese grupo el carcinoma de mama, por la alteración que provoca en la mama y la percepción que puede tener la paciente de un bulto. En los que asientan en el interior del organismo y no tienen manifestación al exterior, los síntomas suelen ser más imprecisos y dan origen a que se diagnostiquen más tardíamente.
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