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BMS bags US approval for Opdivo and Yervoy combo

Marks first approval for joint use of two immuno-oncology drugs
Bristol Myers Squibb

BMS has received FDA approval for a combination of its melanoma drugs Yervoy and Opdivo.

The approval comes on the back of data from the Checkmate-069 study which showed improved response rates and longer progression-free survival (PFS) with Opdivo (nivolumab) and Yervoy (ipilimumab), compared to Opdivo and Yervoy alone.

Median average PFS for Yervoy was 2.9 months, 6.9 months for Opdivo and 11.5 months for both drugs combined.

The combination of both drugs marks the first and only FDA approval of a regimen of two immuno-oncology agents in cancer. However, the combination will cost and around $250,000 for the first full year and $150,000 thereafter, raising questions about its affordability.

Additionally, in the group taking both drugs, around of third of patients discontinued treatment due to adverse reactions including diarrhoea, rash and colitis.

Yervoy is a CTLA4 inhibitor and the first drug of its kind to be approved in 2011. It followed onto the market by PD-1 inhibitor Opdivo in 2014.

Sales of Opdivo reached $162m in the first half of the year across all its indications while Yervoy reached $621m, representing a 5% growth from last year.

Forecasts for Opdivo's peak sales range between $5bn and $7.3bn and analysts expect immuno-oncology drugs, either used alone or in combination, to bring in tens of billions of dollars in peak revenues.

The new combination will now be in competition with the likes of Merck & Co's  Keytruda (pembrolizumab), which is indicated for patients with melanoma following treatment with Yervoy and other BRAF inhibitors such as Roche's Zelboraf (vemurafenib) and GSK's Taflinar (dabrafenib).

The market for melanoma as a whole is expected to reach in excess of $2.8bn by 2021 across the US and Europe, driven by increasing patient numbers and the growth of marketed drugs as well new treatment options for the condition.  

Article by
Nikhil Patel

6th October 2015

From: Regulatory

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