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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.