Posted from: Monday, April 06, 2015 - 11:23 AM - Present

Expanded Indication for Opdivo

February 27, 2015 – The U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab), manufactured by Bristol-Myers Squibb, for treating metastatic squamous non-small cell lung cancer (NSCLC) that progresses during or after treatment with platinum-based chemotherapy. It was first approved in December 2014, to treat melanoma that has spread, that cannot be removed or that no longer responds to drug treatment.

Opdivo, a human programmed death receptor-1 (PD-1) inhibitor, interferes with a protein that keeps the immune system from fighting cancer cells. It will be given as a one-hour intravenous (IV) infusion once every two weeks until the cancer advances or the patient cannot tolerate additional infusions.

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 Monday, March 20, 2017 - 02:42 AM.