Posted from: Wednesday, May 16, 2018 - 04:27 PM - Present

Opdivo-Yervoy Combination Approved for Kidney Cancer

April 16, 2018 – The U.S. FDA has approved a combination of Opdivo (nivolumab) 3mg/kg and low-dose Yervoy (ipilimumab) 1mg/kg as a first-line treatment for intermediate- and poor-risk advanced renal cell carcinoma (RCC). It is the first immuno-oncology pairing to receive this indication. Both Opdivo and Yervoy are manufactured by Bristol-Myers Squibb.

Approval was based on clinical trials in which the Opdivo-Yervoy combination was found to be superior to the current standard of care, Pfizer’s Sutent® (sunitinib). The Opdivo-Yervoy combination significantly increased overall survival rates regardless of PD-L1 expression level and achieved a higher objective response rate. Patients who received the combination also experienced fewer severe or life-threatening adverse events compared to those taking Sutent. Risk of death was reduced by 37% with Opdivo-Yervoy versus Sutent, and the objective response rate was 41.6% compared to just 26.5% with Sutent.

Recommended dosing is one infusion every three weeks of Opdivo 3mg/kg and Yervoy 1mg/kg, for a total of four doses. Monotherapy then follows with Opdivo 240mg every two weeks or 480mg every four weeks.

An estimated 75% to 80% of patients diagnosed with advanced RCC are considered intermediate- and poor-risk patients. The population has a survival rate of just 36% after one year, and 8% after five years.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Sunday, November 18, 2018 - 10:04 AM.