
Roche’s Tecentriq combo recommended in Europe for non-small cell lung cancer
pharmafile | July 29, 2019 | News story | Sales and Marketing | Cancer, NSCLC, Roche, lung cancer, pharma, tecentriq
Riche’s blockbuster immunotherapy Tecentriq (atezolizumab) is closing in on securing yet another approval after it revealed that the drug was awarded a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The recommendation covers Tecentriq’s use in combination with carboplatin and Abraxane chemotherapy in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumours are not EGFR mutant or ALK-positive.
While the decision does not guarantee an approval in the aforementioned indication, recommended products do often go on to become approved. Phase 3 trial results showed that the Tecentriq combo improved median overall survival by 18.6 months compared to 13.9 months with chemotherapy alone, and “significantly reduced” the risk of disease progression or death by seven months compared to 5.5.
“We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based lung cancer combination for people living with non-squamous non-small cell lung cancer,” said Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a complex disease that requires a range of treatment options. We are now one step closer to providing another important alternative for this difficult-to-treat form of cancer.”
Roche said that it expects a final approval decision from the European Commission in the “near future”.
Matt Fellows
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