Topic: soft tissue sarcomas
An FDA panel voted 11-0 to recommend approval of Epizyme's tazemetostat for a rare, aggressive soft tissue cancer.
One analyst said the conclusions “read a bit harsh,” leading them to put the chances of a positive vote at no more than 25%.
Epizyme has posted updated data from the phase 2 trial it hopes will secure tazemetostat approval in epithelioid sarcoma.
Updated data show an objective response rate of 13% across 62 patients; treatment-naïve patients fared better than relapsed or refractory patients.
A top-line success against the pathological complete response rate endpoint in soft tissue sarcoma sent Nanobiotix’s stock up by more than 50%.
The early data raised hopes the GSK-partnered drug will be effective in multiple types of solid tumor, sending Adaptimmune shares up nearly 20%.
Eli Lilly spent nearly a quarter of its income on R&D last year, putting it near the top of its peers in percentage terms, and saw some of that spend pay off—overall, however, last year was a mixed bag for the company’s research.
En route to its accelerated approval in October, Eli Lilly’s olaratumab seemed to rack up every possible shortcut from the FDA—fast-track and breakthrough therapy designations as well as priority review and orphan drug designation.
Fast-track designation, breakthrough therapy designation, priority review, orphan drug designation, and now, finally, Eli Lilly gets the full house with an approval for its soft tissue sarcoma med in the U.S.
Days after Eli Lilly announced that Richard Gaynor, its SVP of clinical development for its oncology biz, would be retiring, the Big Pharma has announced a much-needed boost that its experimental bone cancer drug olaratumab has been recommended for approval in Europe.