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FDA gives early green light to Spectrum’s lymphoma drug

Beleodaq approved to treat rare cancer

FDA headquarters White OakSpectrum Pharmaceuticals is celebrating an early approval from the US FDA for Beleodaq, a therapy for a rare form of non-Hodgkin's lymphoma (NHL).

Beleodaq (belinostat) has been cleared to treat peripheral T-cell lymphoma (PTCL), a particularly fast-growing form of lymphoma that affects around 10-15 per cent of the 70,800 NHL cases reported in the US each year. It can be used in patients who have relapsed or have not responded to prior treatment.

Beleodaq is a novel HDAC inhibitor – licensed from Denmark's TopoTarget - which works by inhibiting enzymes that drives the transformation of healthy T cells into malignancy, and is Spectrum's fifth approved product, according to the firm's chief executive Rajesh Shrotriya.

“PTCL is a fatal disease [and] really difficult to treat,” said Shrotriya, adding that the most effective drugs for the disease have a 25 to 30 per cent response rate and even responders typically progress within a year.

That means multiple lines of therapy are required, a Beleodaq joins two other PTCL therapies approved by the FDA in the last five years. Spectrum's Folotyn anti-folate drug (pralatrexate) was cleared in 2009 for use in patients with relapsed or refractory PTCL while Celgene got the nod for its HDAC inhibitor Istodax (romidepsin) in 2011 for the treatment of PTCL in patients who received at least one prior therapy.

Spectrum claims Beleodaq has a broader mechanism than Istodax – blocking three different forms of the HDAC enzyme compared to one for Celgene's drug - although no head-to-head trials of the two drugs have been carried out. That profile could also reduce the risk of low platelet counts (thrombocytopenia), according to the company.

Beleodaq's approval comes on the back of a study involving 129 relapsed or refractory PTCL patients who were treated with Beleodaq until their disease progressed or side effects became intolerable. Results showed 25.8 per cent of participants had their cancer disappear or shrink after treatment, according to the FDA.

The US approval sparks a $25m milestone payment to TopoTarget, which is in the throes of a merger with BioAlliance Pharma.

Spectrum could also secure approval in the coming months for a sixth product – a captisol-enabled formulation of melphalan – as a condition agent for use in patients undergoing stem cell transplantation for multiple myeloma. Unlike current melphalan products the new formulation does not have any propylene glycol, which has been linked to cardiac side effects.

Article by
Phil Taylor

4th July 2014

From: Sales, Regulatory



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