FDA advisory panel votes against approval of Novartis MM drug

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) did not recommend Swiss pharma major Novartis’ (NOVN: VX) investigational compound LBH589 (panobinostat), a pan-deacetylase (pan-DAC) inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib (Johnson & Johnson’s Velcade) and dexamethasone.

The Committee's vote of five to two will be considered by the FDA in its review of the panobinostat New Drug Application, but the agency is not bound to follow the Committee's guidance. The final decision regarding US approval is made by the FDA.

"We are disappointed by this voting outcome and believe the results from our clinical trials provide strong evidence to support LBH589 as a potential first-in-class treatment option for multiple myeloma, a cancer where an unmet patient need exists," said Bruno Strigini, president, Novartis Oncology, adding: "We will continue to work with the FDA as it completes its review of the US application."