NICE Recommends Cell Therapeutics' PIXUVRI For B-Cell NHL
Seattle-based Cell Therapeutics, Inc. (CTI) reported that the National Institute for Health and Care Excellence (NICE) has given its final guidance recommending PIXUVRI (pixantrone) as monotherapy for treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL) including diffuse large B-cell lymphoma. NICE is the independent authoritative body which drives improvement and excellence in the health and social care system in the UK.
James A. Bianco, CTI President and Chief Executive Officer, said, “NICE's final guidance on PIXUVRI means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting…We hope the NHS commissioners will recognize the lack of suitable treatment options that exist for patients at this stage of the disease and list PIXUVRI on hospital formularies as soon as possible.”
About 1,600 to 1,800 people in the UK are diagnosed with multiply relapsed aggressive B-cell NHL every year, according to CTI. Aggressive B-cell NHL is the most common among NHL subtypes and accounts for about 55% of all NHL cases. One-third of patients usually develop progressive disease after initial therapy for aggressive NHL with anthracycline-based combination therapy.
Pixuvri is a novel aza-anthracenedione with unique structural and physiochemical properties enabling it to form stable DNA adducts. In preclinical models, the drug demonstrated superior anti-lymphoma activities compared to related compounds. The active substance in Pixuvri, pixantrone, is cytotoxic and works by interfering DNA within cancer cells. The drug was structurally designed by CTI to avoid anthracycline induced acute and chronic cardiotoxicity. Pixuvri’s novel pharmacologic properties allow it to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
NICE’s final guidance concludes Pixuvri as cost-effective and recommends it as a prescription option to people with histologically confirmed aggressive B-cell NHL, who have previously been treated with rituximab and are currently receiving PIXUVRI as a third- or fourth-line treatment. Pixuvri may be obtained under CTI’s Patient Access Scheme (PAS) agreement with the UK Department of Health.
The company expects NHS to implement the final appraisal determination (FAD) following the NICE final guidance within 90 days. CTI plans to officially launch Pixuvri in England and Wales this spring after the FAD implementation.