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Takeda in myeloma research drive

Published on 14/01/16 at 10:34am
The Phase II study will trial Ninlaro in combination in patients with myeloma

Takeda is funding the research charity Myeloma UK to run a Phase II study of its multiple myeloma treatment Ninlaro, which is open for recruitment.

The Japanese pharma firm is backing Myeloma UK to investigate the benefits of Ninlaro (ixazomib), in combination with cyclophosphamide and dexamethasone, against a combination of cyclophosphamide and dexamethasone in relapsed and/or refractory myeloma patients.

This is the eighth trial to be set up within the Myeloma UK Clinical Trial Network (CTN) and will recruit 250 patients from 20 of the 35 Myeloma UK CTN centres across the UK.

The trial, MUK eight is part-funded by Takeda Oncology. The firm wants to use the trial to complement the regulatory trial TOURMALINE-MM1, which found the drug extended progression free survival by 35% in patients with relapsed and/or refractory multiple myeloma.

The aim of the company and the charity is to provide additional and complementary evidence to support the health technology assessments and NHS commissioning of Ninlaro in the UK. The drug is currently being assessed for approval in Europe.

A spokesperson for Myeloma UK told Pharmafile: “The trial forms part of a partnership with industry and NICE to improve evidence generation for HTA evaluation. The overall aim is to reduce uncertainty, maximise chances for a quicker approval in the UK, and support the seamless adoption and diffusion of new treatments into the NHS.”

Myeloma UK chief executive Eric Low explains: “For far too long there has been a lack of strategic cohesion between the policies that have been put in place at different stages of the drug development cycle, and an absence of forethought or understanding as to how one stage of the process impacts on another.

“As a consequence issues around how new myeloma treatments are appraised, approved for use and commissioned in the UK has resulted in an unacceptable situation whereby patients do not get access to the treatments that they need when they need them. The Myeloma UK Clinical Trial Network aims to address these issues.”

Takeda UK director of market access Ross Selby adds: “We are thankful to Myeloma UK, the investigators and NICE for being open to working together to help increase access for UK patients to innovative drugs such as ixazomib, the first oral proteasome inhibitor.”

While Dr Leeza Osipenko who heads NICE Scientific Advice says: “This was one of the most interesting advice projects we’ve conducted over the years as for the first time we were presented with the plans for the global clinical development programme along with a national trial. We hope this pilot leads to future three-way engagements for early dialogues with the industry and patient organisations.”

Lilian Anekwe

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