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Novartis' Farydak gets nod for myeloma in Europe

HDAC inhibitor offers new mechanism of action in fight against myeloma

Novartis' Farydak has become the first drug in the new HDAC inhibitor class to be approved in Europe for multiple myeloma.

The European Commission has cleared Farydak (panobinostat) for use in relapsed or refractory myeloma patients whose disease has progressed despite at least two rounds of earlier treatment including Takeda/Millennium's Velcade (bortezomib) and an immuno-modulating (IMiD) agent.

Novartis' drug should be given in combination with Velcade and dexamethasone, an anti-inflammatory drug, and provides "a new treatment option for patients living with multiple myeloma whose disease has progressed after standard-of-care therapy," according to the company.

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. 

Panobinostat is thought to thought to work by blocking one of several enzyme classes that modify gene expression in the cell, thereby slowing the over-development of plasma cells or by causing the malignant cells to die.

Novartis says its approval marks "the first time an HDAC inhibitor with epigenetic activity is available in the EU," providing a much-needed additional line of therapy for patients with aggressive myeloma.

"Patients with multiple myeloma often relapse or stop responding to treatments," commented Philippe Moreau, a myeloma specialist at the Centre Hospitalier Universitaire de Nantes in France.

"Farydak offers a new mechanism of action, which may improve the effectiveness of response to standard-of-care treatment in patients."

Novartis had originally planned to seek approval of Farydak in a broader multiple myeloma indication, but was knocked back by an FDA advisory committee which concluded the benefits of the drug did not outweigh its risks.

Other HDAC inhibitors such as Merck & Co's first-to-market Zolinza (vorinostat) - which is approved to treat cutaneous T cell lymphoma (CTCL) in 2006 - have also been tested in myeloma but failed to show efficacy at a dose that was not associated with significant side effects.

In trials, patients treated with Farydak, Velcade and dexamethasone had a median progression-free survival (PFS) of 10.6 months, versus 5.8 months for patients who received Velcade and dexamethasone alone. Additionally, 59% of patients in the Farydak arm showed tumour shrinkage or disappearance after treatment, compared to 41% in the comparator group.

The market for multiple myeloma therapies is becoming increasingly competitive with a number of new drugs nearing or entering the market - including Takeda's oral Velcade-follow-up ixazomib and Bristol-Myers Squibb's just-filed elotuzumab - so sales projections for Farydak are modest. 

Novartis is also developing the drug to treat myelodysplastic syndrome (MDS), myelofibrosis and other haematological malignancies such as acute myeloid leukaemia (AML) and NHL, as well as for melanoma and other solid tumours.

Farydak has also been approved for marketing in the US and Japan.

Article by
Phil Taylor

4th September 2015

From: Regulatory



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