Future bleak for Novartis’ panobinostat in relapsed/refractory multiple myeloma, says analyst

The vote against the recommendation that the US Food and Drug Administration approves Novartis’ (NOVN: VX) panobinostat (Farydak) for use in relapsed/refractory multiple myeloma by the Oncologic Drugs Advisory Committee (ODAC) signals that a US marketing authorization is unlikely to be granted, according to an analyst with research and consulting firm GlobalData.

The ODAC’s negative verdict (The Pharma Letter November 7) was based on results of the Phase III PANORAMA-1 clinical trial, which examined the use of Velcade (bortezomib from Johnson & Johnson) and dexamethasone in combination with panobinostat, versus placebo, in patients with relapsed/refractory multiple myeloma.

Alongside inconsistent data regarding progression-free survival, no statistically-significant overall survival benefit for panobinostat was determined by either the Novartis or the FDA analysis. Although the FDA does not have to follow the ODAC recommendation, it rarely makes the opposite decision.