In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs
Regulatory
FDA requests more data for Opdivo in treating BRAF V600 mutation-positive melanoma
Bristol-Myers Squibb announced that the FDA has requested additional data in its response to its supplemental biologics license application for Opdivo as monotherapy for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
First oncolytic virus vaccine for advanced melanoma
FDA recently approved the first oncolytic virus therapy: talimogene laherparepvec (Imlygic—BioVex/Amgen), a modified live herpes simplex virus type 1 oncolytic virus therapy, for the treatment of recurrent melanoma.
FDA Issues Complete Response Letter for Nivolumab in BRAF-Mutant Melanoma
The FDA has issued a complete response letter to Bristol-Myers Squibb informing the company that additional data were needed for its supplemental biologics license application (sBLA) for the use of single-agent nivolumab (Opdivo) in previously untreated patients with BRAF V600 mutation-positive advanced melanoma. The application was based on the CheckMate-066 trial and additional data for a BRAF-positive group.