Novartis’ Tafinlar/Mekinist recommended for extension in EU

Novartis has received regulatory approval for the Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy in the European Union for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma according to Novartis. This marks the first targeted therapy combination approved in the EU for this aggressive form of skin cancer, offering improved overall survival compared to BRAF inhibitor monotherapy as reported. The approval was based on results from two Phase III clinical trials—COMBI-d and COMBI-v—which demonstrated statistically significant benefits in overall survival and progression-free survival according to clinical data.

The COMBI-d study showed that the combination therapy achieved a median overall survival of 25.1 months compared to 18.7 months with Tafinlar monotherapy according to trial results. Additionally, the combination therapy demonstrated a 69% overall response rate and a median duration of response of 12.9 months as clinical data shows. Safety data from the trials indicated that the most common adverse events included pyrexia, fatigue, nausea, and hypertension, with no new safety concerns observed according to safety analysis.

In 2017, the EU also approved the Tafinlar and Mekinist combination for the treatment of BRAF V600-positive advanced non-small cell lung cancer (NSCLC), marking the first targeted therapy for this subset of lung cancer patients according to Novartis. The approval was based on a Phase II trial showing an overall response rate of over 60% in both previously treated and untreated patients as reported in clinical data.

The Tafinlar and Mekinist combination is currently approved in multiple countries for both melanoma and NSCLC and is being investigated in additional tumor types according to Novartis. The therapy targets the RAS/RAF/MEK/ERK pathway, which is implicated in several cancers, and has shown improved efficacy compared to monotherapy as clinical data indicates.

Despite its benefits, the combination therapy carries potential risks, including the development of new cancers, severe bleeding, and heart-related complications according to safety information. Patients are advised to monitor for adverse effects and follow medical guidance closely as recommended.

The approval of Tafinlar and Mekinist in the EU reflects Novartis' ongoing commitment to developing targeted therapies for oncology patients with unmet medical needs according to company statement.