FDA approves combination therapy involving Amgen’s Kyprolis cancer drug

The agency approved Kyprolis in combination with dexamethasone or with lenalidomide plus dexamethasone to treat patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

The drug has also been approved as a single agent to treat patients with relapsed or refractory multiple myeloma who had one or more earlier treatments.

The FDA’s decision converts Kyprolis’ single-agent accelerated approval in the current setting to a full approval.

In July 2012, the FDA granted an accelerated approval to Kyprolis monotherapy to treat patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on or within 60 days of the completion of the final therapy.

The agency’s latest approval was based on results from the phase 3 head-to-head Endeavor study, which demonstrated that Kyprolis and dexamethasone doubled progression-free survival, when compared to velcade (Bortezomib) and dexamethasone.

Amgen executive vice president of research and development Sean Harper said: "Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs.

"Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."

Kyprolis is a product of Amgen’s subsidiary Onyx Pharmaceuticals, which holds global development and commercialization rights to the drug, excluding Japan.

Image: Kyprolis for injection is indicated in combination with lenalidomide and dexamethasone to treat multiple myeloma who have received one to three prior lines of therapy. Photo: courtesy of Amgen Inc.