R&D Briefs: Alprolix Approval Bodes Well, T-VEC Stumbles, Curis Back On Track
FDA approves Biogen’s long-acting hemophilia drug Alprolix and lifts clinical hold on Curis’ cancer drug CUDC-427, but Amgen’s announcement that its melanoma vaccine T-VEC failed to improve survival clouds its chances with the agency.
You may also be interested in...
Patient Voices Swayed FDA's Imlygic Review Team
Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.
Amgen’s T-VEC AdCom May Shed Light On How FDA Reviews Intralesional Immunotherapies
FDA’s Oncologic Drugs and Cellular, Tissue and Gene Therapies advisory committees will weigh in on a new molecular entity in a nascent field of cancer vaccines April 29; could set precedent for other intralesional drug reviews.
Marriage Of Kite’s CAR-T Platform To Amgen Targets Will Expand Pipeline For Both
Kite’s initial partnership with another biopharma sees it bringing its CAR-T platform technology to bear on Amgen’s oncology targets. Each company could develop new cancer immunotherapy products out of the collaboration, with earn-outs for the other.