Posted from: Tuesday, January 16, 2018 - 12:31 PM - Present

Opdivo Receives New Indication

December 20, 2017 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab), manufactured by Bristol-Myers Squibb. The drug is now approved as an adjuvant treatment for patients who have melanoma with involvement of lymph nodes or who have metastatic disease that has been resected completely.

A programmed death receptor-1 (PD-1) blocking antibody, Opdivo works by helping the immune system target and attack cancer cells. It was found in a clinical trial to reduce the recurrence of melanoma by 35%. During the trial, 66.4% of patients who received Opdivo were free of relapse for at least 18 months. This is an improvement over patients who received Yervoy® (ipilimumab), also manufactured by Bristol-Myers Squibb; 52.7% of those patients remained free of relapse for 18 months or more. Opdivo was also less likely than Yervoy to cause serious side effects that halted therapy.

Recommended dosing with Opdivo is based on indication. The drug is approved to treat a number of different types of cancer, and is administered via intravenous (IV) infusion.

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 Friday, May 18, 2018 - 11:24 PM.