On heels of Loxo buy, Lartruvo setback deals a blow to Lilly's oncology hopes.
by Eric Sagonowsky | Jan 18, 2019 .
After patent expirations and other woes, Eli Lilly has been leaning on a stable of new drugs for growth. But after a trial failure for soft tissue sarcoma launch Lartruvo, the drugmaker is stopping promotion for the drug.
In a phase 3 trial, the drug failed to confirm an overall survival benefit for patients with advanced or metastatic soft tissue sarcoma, Lilly reported. The drug won its U.S. and European approvals based on a phase 2 trial that did show it could help patients live longer.
Now, Lartruvo is in crisis mode. Lilly is “working with global regulators to determine the appropriate next steps” for the med and is taking a pre-tax charge of $70 million to $90 million this quarter. For the year, it expects a 17-cent hit to earnings per share from the trial failure. ...
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 .
