FDA not bound to follow Committee’s guidance its review of LBH589 NDA
Novartis announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not recommend the investigational compound LBH589 (panobinostat), a pan-deacetylase (pan-DAC) inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib and dexamethasone.
The committee’s vote will be considered by the FDA in its review of the LBH589 new drug application (NDA), but the FDA is not bound to follow the committee’s guidance. The final decision regarding US approval is made by the FDA.
However, Novartis believes that the compound has the potential to be an important treatment option for multiple myeloma patients and indicated that it will continue working with the FDA on a path forward.
According to a press release from the company, data presented at the meeting included two clinical studies evaluating LBH589 in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma: a phase III randomised, double-blind, placebo-controlled, multicentre global registration trial called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a phase II US multicentre, single-arm, open-label study called PANORAMA-2.
EP News Bureau – Mumbai