Novartis has suffered a setback after advisors to the US Food and Drug Administration voted against recommending approval of panobinostat for multiple myeloma.

The agency’s Oncologic Drugs Advisory Committee voted 5-2 against panobinostat, a pan-deacetylase (pan-DAC) inhibitor, for patients with previously treated multiple myeloma when used in combination with Johnson & Johnson/Takeda’s Velcade (bortezomib) and dexamethasone. The panel was evaluating Phase III data submitted by the Swiss major showing that the combo improved progression-free survival (PFS) by 3.9 months compared to bortezomib and dexamethasone alone.

However, an independent FDA review assessed improved PFS at 2.2 months with panobinostat, also known as LBH589, and some panel members noted their concerns about missing or censored data submitted by the Swiss major. The advisors acknowledged that there was a marginal benefit but said this was outweighed by the panobinostat combo showing twice the incidence of death not due to disease progression and a high incidence of haemorrhage, infection and cardiac toxicity.

Novartis oncology president Bruno Strigini said “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”. He added that “we will continue to work with the FDA as it completes its review”.