European regulatory advisors are backing approval of Novartis’ experimental melanoma combination therapy Tafinlar and Mekinist as well as Revolade for severe aplastic anaemia.
The Committee for Medicinal Products for Human Use has backed Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The decision came on the back of data from the Phase III COMBI-d and COMBI-v studies. The first showed that the combo achieved a statistically significant overall survival (OS) benefit compared to Tafinlar alone (median of 25.1 months vs 18.7 months). OS was 74% at one year and 51% at two years in the combination arm versus 68% and 42% for those taking Tafinlar only, respectively.
The COMBI-v study showed that Tafinlar/Mekinist achieved a statistically significant OS benefit compared to Roche’s vemurafenib (median for the combination not reached vs 17.2 months), and one-year OS of 72% versus 65%, respectively.
Across the pond, US regulators have just agreed to undertake a priority review of the combination based on these results.
Support for Revolade
Elsewhere, the CHMP also adopted a positive opinion for Revolade (eltrombopag) for the treatment of adult patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST) and are not eligible to receive a haematopoietic stem cell transplant.
The decision means Revolade is a huge step closer to becoming the first approved therapy in its class in the EU for patients with the serious blood disorder – where the bone marrow fails to make enough red blood cells, white blood cells and platelets – who have not responded to or are ineligible for existing treatments.
Around 40% of SAA patients who don’t respond to initial IST die from infection or bleeding within five years of their diagnosis, Novartis noted, highlighting the urgent need for new treatment options.
The positive opinion is based on Phase II data showing a haematologic response (40%) in SAA patients treated with Revolade who had an insufficient response to IST. The most common adverse reactions (>=20%) were nausea (33%), fatigue (28%), cough (23%), diarrhoea (21%), and headache (21%).
