BMS’ Opdivo+Yervoy combo secures FDA approval in kidney cancer
pharmafile | April 18, 2018 | News story | Research and Development, Sales and Marketing | BMS, Bristol Myers Swuibb, Cancer, FDA, Yervoy, carcinoma, opdivo, pharma
The FDA has announced its approval of a combination of Opdivo (nivolumab) and Yervoy (ipilimumab), both products from Bristol Myers Squibb, for the treatment of previously untreated advanced renal cell carcinoma which is of intermediate or poor risk.
The US regulator’s decision was based on Phase 3 data derived from the CheckMate-214 trial, wherein 1,096 patients received either a combo of Opdivo and Yervoy every three weeks for four doses followed by Opdivo monotherapy every two weeks, or Pfizer’s Sutent (sunitinib) daily for four weeks followed by two weeks every cycle.
It was found that the combo demonstrated statistically significant improvements in overall survival (OS) and objective response rate (ORR) compared to standard of care; the later statistic stood at 41.6% for the combo compared to 26.5% with Sutent. Estimated median OS was not estimable for the combo, compared to 25.9 months for Sutent.
Around 20% of trial participants experienced adverse reactions including fatigue, rash, diarrhoea , musculoskeletal pain, nausea among them. The combination had already secured US approval in the treatment of melanoma and is currently being tested in other cancer types.
“The approval of this combination immunotherapy is the most significant advance for the treatment of kidney cancer over the last 10 years. Not only is this therapy superior than the current the standard of care, but patients experienced also a better quality of life,” said Dr Hans Hammers, Associate Professor of Internal Medicine and Co-Leader of the Kidney Cancer Program at UT Southwestern. “However, serious side effects can occur which require timely diagnosis and expertise in their management.”
Matt Fellows
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