Posted by Michael Wonder on 24 Sep 2019
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) four week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
24 September 2019 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks or 480 mg infused over 60 minutes every four weeks for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
“This positive CHMP opinion for Opdivo two and four-week dosing reinforces our commitment to offering flexible dosing options for patients, caregivers and healthcare providers,” said Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb. “We look forward to the European Commission’s decision and potentially bringing this new Opdivo dosing regimen to patients as quickly as possible.”
