CHMP recommends EU approval of Roche ’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer
In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by 57% in people with PD-L1 high resectable Stage II-III NSCLC compared with best supportive careMore than half of people with early-stage NSCLC experience disease recurrence following surgery,1 and most of these recurrent tumours are metastatic, making them incurable2-7If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in EuropeBasel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC. A final decision regarding the approval of Tecentriq in this setting is expected from the European Commission in the near future.“The goal of treating early-stage cancers is to provide the best chance for a cure,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s announcement brings hope that, after a decade of limited treatment advances, many people in E urope with early non-small cell lung cancer will soon have a new treatmen...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
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