I suspect Onyx wants to develop carfilzomib as Millennium developed Velcade. So here is a short primer on the data that led to accelerated approval of Velcade:
- 202 patient open label single arm trial, 188 evaluable - median prior therapies: 6 - 5 CRs (3%) - 47 PRs (25%) - Overall response rate of 28% - median response duration of CRs + PRs: 1 year - median time to progression of 7 months - median survival of 16 months (I don't believe this endpoint was reached at time of approval)
So far the carfilzomib data look fine to me. They have definitely been able to remove the peripheral neuropathy side effect that is seen in ~30% of velcade patients. The approval path remains murky to me. It's unclear if the FDA is going to demand data largely from patients who have failed prior Velcade.
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