The FDA has accepted a supplemental biologics license application for the Opdivo plus Yervoy regimen to include data from a phase 3 trial of patients with previously untreated advanced melanoma, according to a press release from Bristol-Myers Squibb.
Regulatory
FDA Grants Nivolumab/Ipilimumab Combination Priority Review for Advanced Melanoma
The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab (Opdivo) plus ipilimumab (Yervoy) in previously untreated patients with advanced melanoma, according to a statement from the regimen’s developer, Bristol-Myers Squibb.
Melanoma New Zealand delighted with KEYTRUDA registration
Melanoma New Zealand is delighted that anti-PD1 immunotherapy KEYTRUDA® (pembrolizumab) has been approved by Medsafe and is now a registered medicine in New Zealand.
Chief Executive Officer of Melanoma New Zealand, Linda Flay, says: “This is an important step for New Zealanders. Along with Australia, we have the highest incidence of melanoma in the world and 30 percent of cases occur in people under the age of 50.
Dabrafenib/Trametinib Combo Granted EU Approval for Advanced Melanoma
The combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) has been approved by the European Commission for the treatment of patients with unresectable or metastatic BRAF V600–positive melanoma, according to a statement from the drugs’ developer, Novartis.