Onyx Pharmaceuticals’ Kyprolis receives positive vote from ODAC

Hannah Blake

pharmaphorum

Onyx Pharmaceuticals, Inc. has announced that the US FDA’s Oncologic Drug Advisory Committee (ODAC) has given a positive vote towards Kyprolis, which is being developed by Onyx Pharma for use in multiple myeloma across a variety of treatment lines.

The result, determined by a vote of 11-0 [with 1 abstention] means that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favourable for use of Kyprolis (the proposed brand name for carfilzomib).

“Today’s ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma. Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review.”

Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals.

The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial, as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.

Completion of the FDA review of the Kyprolis NDA, for accelerated approval, has been set for 27th July 2012. While the ODAC provides the FDA with independent expert advice, the final decision regarding approval is made by the FDA.

Today also marks the beginning of Myeloma Awareness Week, which is currently in its 15th year, to raise awareness and funds to support Myeloma UK's research programme and patient services.