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NICE recommends a new treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Pierre Fabre welcomes the decision of the National Institute of Health and Care Excellence (NICE) to fund BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with of unresectable or metastatic melanoma with a BRAF V600 mutation.
Between 2013 and 2015, about 15,400 cases of melanoma were diagnosed in the UK, about 42 per day. In 2015, melanoma was the fifth most important cancer in the UK, after bad, prostate, lung and intestinal cancer. Metastatic melanoma is badociated with low survival rates, with five-year survival progressively decreasing between stages I and IV.
Encorafenib in combination with binimetinib was approved by the European Union last September for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, detected by a validated test. The EU license was based on COLUMBUS trial data that demonstrated that the combination of 450 mg daily and 47 mg bioreptibib twice daily improves progression-free survival. median (primary endpoint) vs vemurafenib taken alone at 960 mg twice daily (14.9 months vs. 7.3 months, respectively): Danger rate [HR] 0.54, 95% confidence interval [CI]from 0.41 to 0.71; p <0.001).
In addition, as presented to the American Society of Clinical Oncology (ASCO) in June 2018, treatment with encorafenib in combination with bimimétib achieved a median overall survival of 33.6 months, compared to 16, 9 months for patients treated with vemurafenib monotherapy (HR 0.61, 95% CI, 0.47-0.79, par value p <0.0001) in the planned badysis of OS in the patient COLUMBUS test. All secondary efficacy badyzes, including SG, are descriptive in nature.
The rate of treatment discontinuation due to suspected treatment-related adverse events (AEs) was lower with this targeted therapy (6%) compared with vemurafenib (14%). Only 13% of patients receiving concorafenib in combination with binimetinib discontinued treatment because of adverse events, compared to 17% of patients treated with vemurafenib.
"This NICE decision is a positive outcome for patients with BRAF V600 mutant metastatic melanoma, as it will ensure the availability of a new treatment option that has shown improved median progression-free survival." compared to vemurafenib alone, "confirmed Dr. Ruth Board, medical consultant oncologist. at NHS Trust of Lancashire Teaching Hospitals and investigator in COLUMBUS trial. "Every patient is different and it is important to make sure that several treatment options are available in our clinical practice."
"Pierre Fabre has been working with oncologists for 29 years to improve their clinical practice and we are delighted that NICE has so quickly recognized that encorafenib in combination with bimimétib was an effective and cost-effective treatment for appropriate patients," he said. Laura McMullin, Executive Director, United Kingdom and Ireland. "We look forward to continuing to work with patient groups, clinicians and nurses to ensure that patients can access this NHS therapy as quickly as possible."
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