FDA places a partial hold on all venetoclax clinical trials for multiple myeloma (MM) patients
August 8, 2017 – Venetoclax has been approved by the Scottish Medicines Consortium to treat patients with chronic lymphocytic leukemia (CLL). In Scotland, about 600 patients are diagnosed with CLL with approximately 168 new cases diagnosed each year.
The drug works by inhibiting the BCL-2 protein which prevents programmed cell death thus allowing the CLL cells to be destroyed. Seven people in Scotland have already been benefitting from Venetoclax through the early access to review process.
Dr Mike Leach, consultant haematologist at the Beatson West of Scotland Cancer Centre, said:
The SMC approval of Venetoclax is an important decision for patients with difficult-to-treat forms of CLL, particularly in cases where existing treatments have failed and patients have limited options left.
The data and our clinical experience show that patients respond well to treatment with a number achieving complete remission justifying not only today’s acceptance by the SMC but also its inclusion in the latest treatment guidelines. Today’s positive decision has the potential to make a difference to the lives of this patient population.
CLL is the most common type of chronic leukaemia, it is more prevalent in people over 60 and is very rare in people under 40. Men are more likely to develop CLL than women, though it is not clear why.
The SMC carried out their patient and clinician engagement (PACE) process for medicines used for rare conditions before deciding to approve Venetoclax.
Read more:
http://www.scotsman.com/news/health/new-drug-for-leukaemia-gets-go-ahead-in-scotland-1-4524929
https://www.firstwordpharma.com/node/1494788?tsid=17
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