New Dosing Schedule Approved for Opdivo
March 7, 2018 – The U.S. FDA has approved a new monthly dosing schedule for Opdivo® (nivolumab), manufactured by Bristol-Myers Squibb.
Indicated for the treatment of numerous cancers, Opdivo previously was approved only for administration every two weeks at a dose of 240mg. The new dosing option now allows patients to receive Opdivo every four weeks, at 480mg per dose. Opdivo has also been approved for a new, shorter infusion time of 30 minutes for all indications and dosage forms.
According to research presented at the 2017 American Association for Cancer Research (AACR) Annual Meeting, Opdivo demonstrates similar safety and efficacy when administered at 480mg once every four weeks rather than 240mg once every two weeks. The research found a less than 1% difference in response for patients with melanoma, renal cell carcinoma, and non-small cell lung cancer.
The newly approved dosing schedule is anticipated to allow healthcare providers to better customize treatment to meet their patients’ individual needs, and can be implemented immediately by physicians.
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
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