Novartis announced that the FDA has granted priority review of the combination of Tafinlar and Mekinist for adults with unresectable or metastatic melanoma with a BRAF V600 mutation.
MRV Research
Regulatory Filings Move Dabrafenib/Trametinib Combo Closer to Full Melanoma Approval
The FDA has assigned a priority review to an application for the full approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with unresectable or metastatic BRAFV600 mutation-positive melanoma, according to a statement from the drug’s developers, Novartis.
European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) Indication in Europe
Bristol-Myers Squibb Company today announced that the European Medicines Agency (EMA) has validated two of the company’s type II variation applications, which seek to extend the current indication for its Immuno-Oncology agent, Opdivo. Validation of the applications confirms that the submissions are complete and starts the EMA’s centralized review process.
Veliparib Plus Temozolomide for Melanoma Improves Progression-Free Survival
Median progression-free survival with veliparib at two different doses in combination with temozolomide nearly doubled compared with placebo; however, the results did not reach statistical significance, a new study published online ahead of print in the journal Annals of Oncology has shown.