Posted from: Friday, October 30, 2015 - 12:06 PM - Present

Expanded Indication for Opdivo

October 9, 2015 - The U.S. Food and Drug Administration approved an expanded indication for Opdivo (nivolumab – Bristol Myers Squibb). Opdivo is an infused human programmed death receptor -1 (PD-1) inhibitor and the new indication allows Opdivo to be used to treat patients with metastic non-squamous non-small cell lung cancer (NSCLC) that progresses during or after treatment with platinum-based chemotherapy.

Opdivo was originally approved in December 2014 for the treatment of previously-treated patients with unresectable or metastatic melanoma. Then in March, 2015, the FDA approved Opdivo to treat patients with metastatic squamous NSCLC that progresses during or after treatment with platinum-based chemotherapy. Approximately 90% of patients with lung cancer have NSCLC, of which about 70% of the cases are non-squamous.

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. All trademarks are the property of their respective owners.

*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, April 23, 2017 - 07:17 PM.