Yervoy revenue trends
In 4Q17, Bristol-Myers Squibb’s (BMY) Yervoy generated revenues of $269 million, which is ~2% growth on a year-over-year (or YoY) basis and a ~17% decline on a quarter-over-quarter basis. In 4Q17, in the US market and outside the US markets (international markets), Yervoy generated revenues of $181 million and $88 million, respectively, compared to $202 million and $66 million in 4Q16.
In 4Q17, in the US market and international markets, Yervoy witnessed a ~10% decline and a ~42% increase on a YoY basis. In fiscal 2017, Yervoy reported revenues of $1.2 billion, which reflected ~18% growth on a YoY basis. In 2017, Yervoy generated revenues of $908 million and $336 million in US markets and international markets, respectively, compared to $802 million and $251 million in 2016. In 2017, in the US market and international markets, Yervoy witnessed ~10% and ~34% growth on a YoY basis.
In January 2018, the European Commission (or EC) approved the label expansion of Yervoy to include its use for the treatment of pediatric patients over 12 years old with advanced melanoma. In July 2017, the FDA approved Yervoy for the same indication.
In December 2017, the U.S. FDA accepted Bristol-Myers Squibb’s supplemental Biologics License Application (or sBLA) for Opdivo and Yervoy combination therapy for the treatment of intermediate and poor-risk individuals with advanced renal cell carcinoma (or RCC). Previously, the FDA granted “Breakthrough Therapy Designation” to this Opdivo and Yervoy combination for the treatment of advanced RCC. The US FDA has granted priority review to Bristol-Myers Squibb’s sBLA and provided a PDFUA (Prescription Drug Fee User Act) action date of April 16, 2018.
Bristol-Myers Squibb’s sBLA is supported by data from the CheckMate-214 trial. In the CheckMate-214 trial, Opdivo and Yervoy combination met the co-primary endpoints of improvement in overall survival (or OS) and objective response rate (or ORR) compared to sunitinib.