New oral treatment approved for myeloma20 Nov 2015
The FDA approved the first oral proteasome inhibitor, ixazomib (Ninlaro), for second-line combination therapy for multiple myeloma. The approval stipulates use of ixazomib in combination with lenalidomide (Revlimid) and dexamethasone in patients with myeloma in relapse after initial treatment.
“This approval is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed”, said Richard Pazdur, MD, director of hematology/oncology products at the FDA's Center for Drug Evaluation and Research.
Positive outcomes supporting the approval
Principal supporting data for the ixazomib application came from a randomized clinical trial involving 722 patients with relapsed/refractory myeloma. All patients received lenalidomide and dexamethasone and were randomized to ixazomib or placebo. The primary results showed almost a 6-month improvement in progression-free survival in the ixazomib arm. Ixazomib is marketed by Takeda Pharmaceuticals.
The approval of ixazomib follows that of the anti-CD38 antibody daratumumab (Darzilex) and of the histone deacetylase inhibitor panobinostat (Farydak) in February. The FDA previously had granted priority review and orphan drug status to ixazomib.Source: MedPage Today