Novartis combo expands into lung cancer with EU approval
pharmafile | April 4, 2017 | News story | Manufacturing and Production, Sales and Marketing |Â Â NSCLC, Novartis, Tafinlar, mekinistÂ
Novartis has announced that its Tafinlar (dabrafenib) and Mekinist (trametinib) drug combo has been approved by the European Commission (EC) for the treatment of BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC), expanding its use beyond the previously-approved indication for melanoma.
The decision means that patients now have access to a targeted treatment for the disease for the first time in an area with historically limited options.
The EC’s judgement was based on data depicting the treatment’s efficacy in a trial of 36 previously untreated and 57 chemotherapy-treated participants. In the first group, an overall response rate (ORR) of 61.1% was observed, with 68% not progressing after nine months. In the second group, the same dosage presented an ORR of 66.7%.
The combo was given the thumbs up by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in February, following Breakthrough Therapy Designation for the same indication in 2015 and Priority Review at the end of 2016.
“Today’s approval represents an important milestone for the lung cancer community, especially those patients living with the BRAF V600 mutation who previously had few options,” said Bruno Strigini, CEO, Novartis Oncology. “At Novartis we are committed to bringing meaningful scientific advances that fill critical unmet needs to patients.”
BRAF V600-positive NSCLC affects up to 36,000 new patients across the world a year. This approval applies to all 28 EU member states, in addition to Iceland and Norway.
Matt Fellows
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