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www.fdanews.com/articles/173067-novartis-multiple-myeloma-drug-approved-in-eu

Novartis’ Multiple Myeloma Drug Approved in EU

September 11, 2015

The European Commission has approved Novartis’ Farydak as the first histone deacetylase inhibitor for treatment of multiple myeloma available in the EU.

Farydak (panobinostat) is indicated in combination with bortezomib and dexamethasone for patients who have already been treated with at least two prior regimens, including bortezomib and an immunomodulatory agent.

The Commission based its approval on data from a Phase 3 study of 147 people that showed median progression-free survival of 12.5 months with Farydak versus 4.7 months with bortezomib and dexamethasone alone.

In February, the FDA approved Farydak for the same indication under a fast-track designation as an orphan drug, entitling it six additional years of marketing exclusivity.

In November 2014, an FDA advisory committee voted 5-2 not to recommend the drug on its own, citing safety concerns. But Novartis submitted additional data supporting its use in combination with the other drugs.

The FDA approval is contingent upon completion and results of postmarketing studies to be conducted over the next few years to verify Farydak’s clinical benefit. — Jonathon Shacat