BMS’ Opdivo accepted to UK early access scheme
pharmafile | June 30, 2015 | News story | Sales and Marketing | BMS, Cancer, NSCLC, eams, keytruda, opdivo
Bristol-Myers Squibb has scored another first with its new-generation oncology therapy Opdivo, which has become the first lung cancer drug to be approved through the UK’s Early Access to Medicines Scheme (EAMS).
Opdivo (nivolumab) is now available for patients in the UK with advanced metastatic or unresectable squamous non-small cell lung cancer (NSCLC).
BMS has joined Merck, whose skin cancer treatment Keytruda (pembrolizumab) is also approved via the scheme, in becoming available for patients in the UK ahead of being granted market authorisation.
The scheme is overseen by the UK Medicines and Healthcare Products regulatory Agency (MHRA), who assessed a package of clinical data supplied by BMS in 2015.
The MHRA has also awarded Promising Innovative Medicine (PIM) to Novartis’ heart failure drug LCZ696 (sacubitril/valsartan). Being awarded this status is the first stage in obtaining a positive scientific opinion from the MHRA.
The EAMS programme was launched by the UK government in April 2014 to provide severely ill patients with life-threatening conditions access to ground-breaking new medicines that have not yet been given marketing authorisation by the European Commission.
In May the EMA approved Opdivo for the European market for locally advanced or metastatic squamous NSCLC after prior chemotherapy in adults. Once it has been licensed by the European Commission, the EAMS closes to new participants but those enrolled will continue to be provided with the treatment.
Commenting on the announcement, Johanna Mercier, who is general manager of BMS UK and Ireland, says: “Bristol-Myers Squibb is really proud to be leading research in the field of immuno-oncology and to be bringing the benefits of this new way of treating patients with this disease.
“Nivolumab is the first treatment for lung cancer to be made available through the EAMS and we are committed to continued collaboration with policy makers to ensure that UK patients can benefit from our innovative cancer medicines.”
Life Sciences minister George Freeman, who is currently consulting with pharma companies and stakeholders as part of the ongoing Accelerated Access review, says: “Lung cancer is a devastating disease and the positive scientific opinion of nivolumab offers real hope to those who need it most.
“The government is committed to accelerating access to new 21st century medicines and I hope this is just one of many drugs that will be made available to patients through the Early Access to Medicines Scheme, giving them the best possible chance to fight their condition.”
Dr Tom Newsom-Davis, a consultant medical oncologist at Chelsea and Westminster Hospital comments: “Lung cancer is one of the most difficult-to-treat cancers because, once the disease has spread, treatment options are very limited and existing medical options have traditionally offered only modest improvements in survival.
“The decision to grant early access to nivolumab is therefore very positive as it means that patients have the potential to access a new medicine which has shown in clinical studies to offer significant extension of survival.”
Lilian Anekwe
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