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Novartis gets lung cancer OK for Tafinlar/Mekinist combo

It can now be used to treat BRAF V600E-positive NSCLC patients in Europe


Novartis' cancer duo Tafinlar and Mekinist have been given the go-ahead in the EU as a treatment for non-small cell lung cancer (NSCLC), extending the use of the drug beyond melanoma for the first time.

The European Commission has cleared BRAF inhibitor Tafinlar (dabrafenib) and MEK inhibitor Mekinist (trametinib) for patients with advanced or metastatic NSCLC whose tumours bear the BRAF V600 mutation. BRAF V600E-positive NSCLC is particularly hard to manage, with few treatment options and represents around 1-3% of all patients with this form of lung cancer.

Novartis estimates that around 36,000 people each year are diagnosed with BRAF V600-positive NSCLC worldwide and notes the mutation is associated with more aggressive tumours and a poorer prognosis, independent of whether patients are smokers.

The approval has been granted from a phase II trial data - first unveiled at last year's American Society of Clinical Oncology (ASCO) meeting - which showed that Tafinlar and Mekinist achieved an overall response rate of 61% in BRAF V600E­positive NSCLC patients, with 68% showing no disease progression for at least nine months.

The response rate is comparable to what can be achieved with chemotherapy but the duration of response is far superior, with patients typically only gaining a two or three-month stay from progression on chemotherapy.

The FDA has granted priority review to Tafinlar/Mekinist for the treatment of BRAF mutant NSCLC with disease progression on or after platinum-containing chemotherapy. The combination was also filed in Japan for BRAF V600E-positive NSCLC towards the end of last year.

The new approval will lend additional momentum to the uptake of Tafinlar and Mekinist, which grew from $453m in 2015 to $672m last year in the melanoma market, where it competes with Roche's Zelboraf (vemurafenib) and Cotellic (cobimetinib) combination. Roche's duo made around $260m in sales last year.

Keen to maintain its lead Novartis recently started a pivotal trial of its own immuno-oncology candidate PDR001 - a PD-1 inhibitor - in combination with Tafinlar/Mekinist in melanoma patients, and also has a phase I/II trial of the combination in BRAF V600-positive colorectal cancer.

Novartis acquired Tafinlar and Mekinist as part of its asset-swap deal with GlaxoSmithKline (GSK) in 2015.

Article by
Phil Taylor

3rd April 2017

From: Regulatory



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