FDA Extends Review Of Novartis' Myeloma Drug

Novartis announced that the U.S. Food and Drug Administration (FDA) has decided to extend its priority review period for LBH589 (panobinostat) in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.

Panobinostat is a pan-deacetylase (pan-DAC) inhibitor and epigenetic regulator that has potential to help restore defective cell programming in multiple myeloma. Data from the Phase 3 PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) released this year showed that LBH589 improved progression-free survival (PFS) compared with placebo. The company reported that LBH589 also increased median PFS by an average of 4 months in combination with the two drugs in patients with relapsed and/or refractory multiple myeloma. The FDA granted priority review status for LBH589, which cuts the standard 12-month review period to 8 months.

The company expected favorable results for its New Drug Application (NDA) for LBH589, however it was met with a negative outcome from the FDA advisory committee earlier this month. The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending the approval of LBH589 with bortezomib and dexamethasone in the patient population following review of the PANORAMA-1 and PANORAMA-2 studies data. “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,” said Bruno Strigini, President of Novartis Oncology.

The company pursued another meeting with ODAC, which was rewarded by a three-month extension of LBH589’s application with the FDA. Though the FDA is not bound to the ODAC’s opinion, it usually follows its advisory committee’s recommendations.

“We are committed to working with the FDA as they continue to review the LBH589 NDA. Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options,” said Alessandro Riva, Global Head of Oncology Development and Medical Affairs at Novartis Oncology.