New Indication for Opdivo
July 31, 2017 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab), manufactured by Bristol-Myers Squibb, to treat patients 12 years of age and older who have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed despite treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Opdivo is a programmed death receptor-1 (PD-1) checkpoint inhibitor injection for intravenous use. Dosage is 240mg infused once every two weeks until the cancer worsens or the patient is no longer able to tolerate use of the drug.
Opdivo was originally approved in 2014 for the treatment of advanced melanoma. It has since received numerous additional indications for use both alone and in combination with other drugs to treat various types of cancer. Use of Opdivo may be associated with immune-related adverse effects, such as infections of the intestines, liver, kidney, or lungs. These effects can be severe or potentially fatal.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.