[suzierose]

Krypolis heads to ODAC..with hurdles

by suzierose on Mon May 07, 2012 1:10 pm

"At its June 20 meeting the Oncologic Drugs Advisory Committee will have to decide whether a single Phase IIb trial in 266 patients provides strong enough evidence of efficacy for Onyx Pharmaceuticals Inc.’s Kyprolis (carfilzomib) for treatment of relapsed and refractory myeloma to overcome the fact that the study was open-label and had only a single arm.

Onyx has an expanded access program for the drug, a novel, highly selective epoxyketone proteasome inhibitor, in partnership with the Multiple Myeloma Research Foundation. U.S. patients with relapsed and refractory myeloma for whom no satisfactory treatment alternatives are available are eligible.

A potential competitor in this space is Celgene Corp.’s pomalidomide, now in Phase III trials according to the company’s product pipeline chart, following good results in Phase II.

The 266 patients in the pivotal Kyprolis trial had relapsed and refractory multiple myeloma despite having been heavily pretreated with a median of five prior therapies comprising 13 drugs (but a minimum of two prior therapies), including bortezomib and either thalidomide or lenalidom"

http://www.oncologystat.com/news/Onyxs_Kyprolis_Heads_to_ODAC_With_Open_label_Trial_Will_Desperation_Outweigh_Doubts.html