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BMS adds another EU indication to Opdivo’s growing list

Wins European licence to treat high-risk advanced melanoma

OpdivoBristol-Myers Squibb has seen its blockbuster drug Opdivo (nivolumab) broaden its use once again after receiving the go-ahead for another cancer indication from the European Medicines Agency (EMA).

Its PD-1 inhibitor is now set to treat patients - residing in the EU - with melanoma who are at high risk of disease recurrence following complete surgical resection, an indication which has already been approved in the US.

Murdo Gordon, executive vice president and chief commercial officer, BMS, said: “Patients with advanced melanoma often face a poor prognosis and have a disease recurrence rate of 68% of greater, highlighting the need for more effective adjuvant treatments.”

Melanoma is a type of cancer that develops from pigment-containing cells more widely known as melanocytes and the disease categorises into five staging categories from 0 to 4.

However, despite surgical resection of the primary tumour and possible adjuvant treatment, most patients experience recurrence and progress to metastatic disease.

Gordon concluded: “The validation of our application by the EMA is another step forward in our effort to advance immuno-oncology treatments for patients with resected high-risk advanced melanoma.”

The EMA’s approval was no doubt influenced by data from BMS’ CheckMate -238 study, an ongoing phase III, randomised assessment of Opdivo versus Yervoy in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma.

Researchers found Opdivo met its primary endpoint of recurrence-free survival and results were presented at the 2017’s European Society for Medical Oncology (ESMO) based in Madrid, Spain and simultaneously published in the New England Journal of Medicine.

Article by
Gemma Jones

9th November 2017

From: Regulatory

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