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Novartis myeloma drug clears phase III trial

Panobinostat on course to be first in new class of treatment for bone marrow cancer

Novartis building

A drug to treat multiple myeloma developed by Novartis has met its objectives in a phase III trial, setting it on track to become the first in a new class of drugs for the bone marrow cancer.

The compound – called LBH589 (panobinostat) – extended progression-free survival (PFS) when added to background treatment with Takeda/Millennium Pharmaceuticals’ Velcade (bortezomib) and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma.

It works by blocking an enzyme found in cancer cells called pan-deacetylase (pan-DAC), causing them to go into stress and ultimately leading to cell death. It has a similar mechanism of action to Merck & Co’s Zolinza (vorinostat), which is already approved to treat cutaneous T cell lymphoma (CTCL) in the US and is in phase III testing for multiple myeloma.

“Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma,” commented Alessandro Riva, global head of oncology development and medical affairs at Novartis.

The prospects for patients with multiple myeloma have been transformed in the last few years, with patients living two to three times longer than they did a decade ago. The improved prognosis is due to a raft of new therapies that have created a market worth some $4.5bn in 2012, despite the fact that only 50,000 cases of the disease are diagnosed worldwide each year.

The market is currently dominated by both Velcade and Celgene’s Revlimid (lenalidomide), although other recent entrants – including Onyx’ Kyprolis (carfilzomib) and Celgene’s pomalidomide – will drive continued growth for the next decade, according to a recent report by Decision Resources.

At the moment there are around six agents in phase III testing and almost 40 in phases I and II. This is likely to make it increasingly difficult for newer agents to make the blockbuster sales levels achieved by the current market leaders.

Phil Taylor
9th December 2013
From: Research
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