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BMS' Opdivo gets two new indications in Europe

Receives green light as lung and kidney cancer immunotherapy

Bristol-Myers SquibbThe roll-out of Bristol-Myers Squibb's PD-1 inhibitor Opdivo continues apace, with the company picking up new approvals for the cancer immunotherapy in lung and kidney cancer in the EU.

The new indication in non-small cell lung cancer (NSCLC) is for patients with non-squamous cell-derived tumours who have previously been treated for the disease with chemotherapy - adding to its existing second-line use in squamous NSCLC and for newly-diagnosed and previously-treated melanoma.

The approval is based on the CheckMate-057 study, which showed that BMS' drug was able to reduce the death rate by 27% compared to docetaxel, a standard therapy for NSCLC. 

Opdivo's US label was expanded to include both squamous and non-squamous NSCLC - regardless of whether the patients' tumours expressed a marker called PD-L1 - last October. Merck & Co's rival drug Keytruda (pembrolizumab) is also approved for squamous and non-squamous NSCLC but only PD-L1 expressing tumours.

Meanwhile, Opdivo (nivolumab) has also become the first PD-1 inhibitor to be approved in Europe as a second-line treatment after chemotherapy for renal cell carcinoma (RCC), ahead of Keytruda. Opdivo was approved for RCC in the US last November.

In the CheckMate-025 trial, BMS' drug reduced the risk of death by 27% compared to Novartis' Afinitor (everolimus) in this patient population. The five-year survival rate for patients diagnosed with this form of kidney cancer is 12%, in part because most first-line therapies provide a short-term benefit and eventually lose their efficacy.

The new approvals will help Opdivo maintain its lead in the marketplace over Keytruda. BMS' drug brought in $942m in worldwide revenues last year - the bulk of which ($823m) came from the US - and the new approvals will also help swell ex-US revenues from the drug.

Keytruda is playing catch-up at the moment with sales of $566m over the same period in its approved indications of melanoma and NSCLC.

Article by
Phil Taylor

7th April 2016

From: Regulatory

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