NICE recommends Yervoy
pharmafile | June 13, 2014 | News story | Sales and Marketing | BMS, Cancer, Dillon, NHS, NICE, Yervoy, melanoma
Bristol-Myers Squibb has received a lift from the UK’s drugs watchdog, which has recommended its vaccine Yervoy as a first-line treatment on the NHS for skin cancer.
In final draft guidance, the National Institute for Health and Care Excellence (NICE) proposes that Yervoy (ipilimumab) should be made available as a first treatment for patients with advanced malignant melanoma, when the tumour either cannot be removed or the cancer has spread to other parts of the body.
In 2010, 10,656 people were diagnosed with malignant melanoma in England although there are no figures pinpointing at what stage of the disease this diagnosis arose.
Immuno-oncology has become a major area for BMS in recent years, with Yervoy bringing in stellar sales and reaching blockbuster status since its launch in 2011.
“We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first-line treatment too,” explains Sir Andrew Dillon, NICE’s chief executive.
In previous draft guidance out for consultation earlier this year, NICE recommended that Yervoy should only be used by the NHS for patients in clinical trials – but BMS tipped the balance by producing more data.
“This information consisted of additional analysis of the existing data which demonstrated the degree to which the approved dose of ipilimumab can extend life when compared with current standard care in the NHS,” Sir Andrew says.
Before the consultation, NICE looked at the CA184 024 trial, which assessed Yervoy 10 mg/kg plus chemotherapy agent dacarbazine – which is not the drug’s licensed dose of four lots of 3 mg/kg alone over 12 weeks.
But the committee saw an overall survival gain of at least three months for patients treated with Yervoy and, after BMS made ‘several adjustments’, it decided that it could use this trial for estimating the clinical effectiveness of the licensed 3 mg/kg dose.
Adam Hill
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