At the Oncologic Drugs Advisory Committee (ODAC) hearing yesterday in Silver Spring, Maryland, the committee voted to approve carfilzomib for use in the relapse/refractory setting (11 yes; one abstention). This strong support indicates a high likelihood of FDA approval—with the final decision due by July 27th.
The presentations from key opinion leaders Dr. Kenneth Anderson and Dr. Sagar Lonial were very strong in support of approval. IMF representatives Robin Tuohy (Director of Support Groups) and her husband Michael Tuohy, and Diane Moran (Senior Vice President Strategic Planning) also made very powerful and emotional statements emphasizing the unmet need and the blunt reality that without new drugs thousands of relapsing myeloma patients would die without access.
The panel seemed persuaded by the arguments and—with remarkably few questions—voted to support approval.
This bodes well for upcoming reviews of additional new agents such as pomalidomide. The ODAC approval acknowledges that there is an unmet need, and that new options are essential and crucial to keep myeloma patients alive while we search for the cure.
Complete review of new treatment landscape: http://imfworkshop.eventresult.com/