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Roche closes on EU approval for Tecentriq in breast cancer

July 01, 2019 / Phil Taylor

Roche is heading for EU approval of Tecentriq as first-line therapy for triple-negative breast cancer (TNBC), ahead of its checkpoint inhibitor rivals. The Committee for Medicinal Products for Human Use (CHMP) backed the use of the PD-L1 inhibitor in patients with locally-advanced or metastatic TNBC that cannot be treated with surgery and who haven’t previously received chemotherapy. The EMA typically approves drugs a few weeks after a positive CHMP opinion. The new indication – which was approved by the FDA in March – is seen as a big commercial opportunity for Tecentriq (atezolizumab) as it is the first checkpoint inhibitor to be cleared for use in any form of breast cancer. It not only represents a sizeable patient population, affecting around 15% of the 2 million women diagnosed with breast cancer each year worldwide, but also has no competition yet from other cancer immunotherapies such as Merck & Co/MSD’s market leading Keytruda and Bristol-Myers Squib...