The European Commission has approved talimogene laherparepvec (T-VEC; Imlygic) as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.
Regulatory
Cobimetinib in BRAF-Mutant Unresectable or Metastatic Melanoma in Combination With Vemurafenib
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
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.