Posted from: Tuesday, May 31, 2016 - 03:38 PM - Present

Approval Opdivo for Hodgkin Lymphoma

May 17, 2016 – The U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) manufactured by Bristol-Myers Squibb, for  treating classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation Adcetris® (brentuximab vedotin – Seattle Genetics). Opdivo injection is a human programmed death receptor-1 (PD-1) immune checkpoint inhibitor that was first approved by the FDA in December 2014. It is also indicated to treat certain patients with advanced melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). The recommended dose is 3mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

 

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 regular mail or by fax.

Actual drug patent expiration dates and a 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 19, 2017 - 11:38 PM.