The Committee for Medicinal Products for Human Use in the European Union recommended denial of a change to the marketing authorizations already in place for the drugs Opdivo (nivolumab) and Yervoy (ipilimumab), according to the European Medicines Agency.
Bristol-Myers Squibb (New York, NY) asked the committee to consider authorizing marketing for use of both drugs in combination to treat patients with untreated, advanced renal cell carcinoma.
According to the European Medicines Agency, “Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing whether Yervoy contributed to these results and if so, how much. It is known that Opdivo alone produces benefit in previously treated patients with renal cell carcinoma.” Another objection was that the “combination with Yervoy resulted in more side effects than are seen with Opdivo alone.” The committee noted that “it is vital that the contribution of each component of the combination, and its appropriate dose, is properly established and justified to avoid giving unnecessary or ineffective treatments.”
Bristol-Myers Squibb has requested a re-examination of the opinion, PharmaPhorum.com noted.
The disappointing news for Bristol-Myers Squibb comes at a time when quarterly figures showed that Merck & Co’s rival PD-1 class drug Keytruda (pembrolizumab) overtook Opdivo in sales “after playing catch-up for several years,” PharmaPhorum.com noted. Merck is based in White House Station, NJ.
Comparing second-quarter sales in 2017 with those in 2018, sales of Keytruda rose 89.2% to $1.67 billion and just passed Opdivo, which saw revenues increase 36% and generated sales of $1.65 billion during the same time frame, PharmaPhorum.com reported.
In April 2018, the FDA approved an Opdivo plus low-dose Yervoy combination as the first treatment to show significantly superior overall survival benefit when compared with sunitinib (brand name Sutent), manufactured by Pfizer (New York, NY).
