20 octubre 2016

FDA Aprueba Olaratumab ( Lertruvo de Lilly ) para el Tratamiento de Sarcomas en Adultos en combinación con Doxorubicin .

* La FDA Autoriza la comercialización para Lartruvo (olaratumab) para el tratamiento de adultos con sarcoma de tejidos blandos avanzado. 

Eli Lilly and Company logo.
* Lartruvo se va a utilizar en combinación con doxorrubicina (un medicamento de quimioterapia) en pacientes con sarcoma de tejidos blandos avanzado, para quienes la cirugía o la radioterapia no es adecuado, y que no han sido tratados previamente con doxorrubicina.



FDA Approves Lilly's LARTRUVO™ (olaratumab) in Combination with Doxorubicin for Soft Tissue Sarcoma .

-- LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for soft tissue sarcoma in four decades .

-- The approval was based on results from the positive Phase 2 JGDG trial .

-- LARTRUVO received the FDA's Breakthrough Therapy Designation and was approved under the Agency's Accelerated Approval program .

...

Median OS was improved by 11.8 months in patients randomized to receive LARTRUVO plus doxorubicin compared to patients randomized to doxorubicin alone, and was statistically significant. Median OS was 26.5 months (95% CI: 20.9, 31.7) on the LARTRUVO-doxorubicin arm compared to 14.7 months (95% CI: 9.2, 17.1) on the doxorubicin-only arm (stratified hazard ratio ...