NORTH HOLLYWOOD, Calif.--(BUSINESS WIRE)--The International Myeloma Foundation (IMF) – improving the quality of life of myeloma patients while working toward prevention and a cure – expressed its disappointment at today’s 5-2 vote by the Oncologic Drugs Advisory Committee (ODAC) against recommendation of FDA approval for HDAC inhibitor panobinostat in combination with bortezomib (Velcade) and dexamethasone for patients with relapsed and refractory multiple myeloma.
“Although we were hopeful that myeloma patients would gain a new treatment option, the ODAC committee determined that the benefits did not outweigh the risks,” said Dr. Brian Durie, Chairman of the IMF.
Novartis’s panobinostat would have been the first drug in its class, a histone deacetylase (HDAC) inhibitor, to be approved for the treatment of myeloma. It is also the first myeloma drug to be turned down in recent years, noted Dr. Durie.
Although disappointed on behalf of myeloma patients, Dr. Durie said the ODAC committee made the correct decision given the toxicities associated with panobinostat. The side effects included serious diarrhea, fatigue, and low blood platelet levels. In addition, the FDA’s re-examination of the panobinostat data resulted in a reduced PFS. “The progression-free survival as analyzed by the FDA dropped from 3.9 months to 2.2 months. We need to set the bar higher.”
While there have been challenges in bringing HDAC inhibitors online for myeloma patients, IMF President Susie Novis said that today’s ruling can be viewed in a positive light. “The ODAC vote today says the system is working,” said Novis. “Myeloma patients can rest assured that they’re not going to be given drugs that aren’t ready for prime time.”
“We know that this particular class of drug has faced challenges, but the good news for myeloma patients is that there is a very healthy pipeline of new drugs on the way,” said Dr. Durie. Other HDAC inhibitors are in development, including ACY-1215 from Acetylon, a next-generation, selective HDAC inhibitor. “We hope that greater efficacy and lesser toxicity can be demonstrated with this or other new agents.”
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Established in 1990, the International Myeloma Foundation (IMF) is the oldest and largest foundation focusing specifically on multiple myeloma. The Foundation’s reach extends to more than 350,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2013, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Follow the IMF on Twitter @IMFmyeloma.
