By Neetha Mahadevan
FRANKFURT--Bayer AG (BAYRY) and Onyx Pharmaceuticals (ONXX) Tuesday said a Phase III Trial of sorafenib, an adjuvant therapy for a form of liver cancer, did not meet primary endpoint.
"We are disappointed that the trial did not meet its primary endpoint. However, we remain committed to exploring the full potential of sorafenib in all stages of liver cancer," Joerg Moeller, member of the Bayer HealthCare Executive Committee said.
The oral multi-kinase inhibitor sorafenib, also called Nexavar, is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.
This outcome does not affect the currently approved indications, the company said. Nexavar is also being evaluated by Bayer and Onyx in a range of other cancers.
Nexavar is co-developed by Onyx Pharmaceuticals, an Amgen subsidiary, and Bayer, and they share profits globally, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights.
DESPUES DE 18 AÑOS CON SOLO TOPOTECAN CON FULL APPROVAL EN EEUU COMO TREATMENT 2a LÍNE SCLC-ES ... LA USFDA ACABA DE APROBAR AL TARLATAMAB CON FULL APPROVAL ... POR LO QUE ES YA EL NEW TREATMENT STÁNDARD EN EEUU . TIENE APROBACIÓNES ACELERADAS EN CANADA , UK, COREA ... Y EN DÍAS PODRÍA ALCANZAR LA APROBACIÓN TAMBIÉN EN CHINA QUE EN JULIO 2025, LA NMPA ACEPTÓ LA SOLICITUD DE REGISTRO (NDA) PARA TARLA OTORGÁNDOLE ADEMAS LA REVISIÓN PRIORITARIA . LA EMA TAMBIÉN LO ESTÁ YA EVALUANDO .