P.D. : J&J presento ante la FDA en el 2008 Dos Dossiers de Dos Farmacos Oncologicos para su Aprobación :*.- Yondelis para Cáncer de Ovario Recurrente combinado con Doxil .
*.- Doxil para Cáncer de Mama Avanzado combinado con Taxotere .
La FDA Pidió más datos para que dichos Farmacos pudieran ser aprobados .
En Abril 2010 J&J anunciaba que Suspendia el desarrollo para conseguir la aprobación del Doxil Combinado con Taxotere en el Tratamiento del Cáncer de Mama .
A J&J solo le queda el Yondelis como Farmaco Oncologico Presentado ante la FDA y por Tanto se centra total y exclusivamente con la Apuesta de conseguir la Aprobación del Yondelis para Cáncer de Ovario ... tal como lo publica la propia J&J en su Presentación de Farmacos seleccionados para Registro ( Picar Titular ... paginas 1 y 2 ) .***************************************************************
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J&J Anunciando la suspension de registro del Doxil en Cáncer de Mama :
http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201005211125dowjonesdjonline000528&title=jandj-drops-development-of-doxil-as-breast-cancer-treatment
J&J Drops Development Of Doxil As Breast Cancer Treatment
By Peter Loftus, Of DOW JONES NEWSWIRES
Johnson & Johnson (JNJ) has formally discontinued efforts to win U.S. regulatory approval to market its drug Doxil as a treatment for advanced breast cancer, citing negative feedback from regulators.
J&J discontinued the development program in April, according to a recent update on its website.
Doxil is currently approved to treat ovarian cancer, multiple myeloma and an AIDS-related disorder. In 2008, J&J sought to widen the market for the drug by filing for U.S. Food and Drug Administration approval to market Doxil as a treatment for advanced breast cancer in combination with Sanofi-Aventis SA's ( SNY, SAN.FR) Taxotere. A study suggested the regimen could delay disease progression versus Taxotere alone.
But last year, an FDA advisory committee recommended against agency approval, saying the drug's risks appeared to outweigh its benefits in treating breast cancer. The drug's known risks include heart-related side effects, according to its prescribing label.
In September, the FDA issued a so-called "complete response" letter for the application, declining to approve it.
"The FDA's feedback was that the risk/benefit ratio for Doxil was not in favor of approval," said J&J spokeswoman Lisa Vaga. "Based on the FDA's feedback, we made the decision to discontinue further development in this indication."
Merck & Co. (MRK) markets the same drug under the brand name Caelyx outside the U.S.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289
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