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CompileKe Ke
Recently, Roche announced that the European Medicines Agency (EMA) Committee for Human Use of Medicines (CHMP) recommended to approve Tecentriq® (atezolizumab, atezolizumab) as a tumor with high PD-L1 expression and no epidermal growth factor receptor (EGFR) Or the first-line (initial) treatment of metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) gene tumor aberrations.
Based on this recommendation, it is expected that the European Commission will make a final decision on the approval of Tecentriq for the treatment of this indication in the near future, as well as the full details of the approval.
If approved, Tecentriq will provide a new treatment plan that will not produce chemotherapy-related adverse reactions.
CHMP’s recommendations are based on data from the phase 3 clinical study IMpower110, which shows that Tecentriq monotherapy can improve overall survival (OS) in people with high PD-L1 expression (TC3 or IC3 wild-type [WT]) compared with chemotherapy 7.
IMpower110 is a randomized, open-label Phase 3 study that evaluates Tecentriq monotherapy compared with cisplatin or carboplatin, pemetrexed or gemcitabine (chemotherapy) in PD-L1 selected, non-chemotherapy phase IV non- Efficacy and safety in patients with squamous or squamous NSCLC.
Tecentriq monotherapy until disease progression (or loss of clinical benefit as assessed by the investigator), unacceptable toxicity or death; or cisplatin or carboplatin (at the investigator's discretion) combined with pemetrexed (non-squamous) or gemcitabine (Squamous), and then maintenance therapy with pemetrexed alone (non-squamous) or optimal supportive therapy (squamous) until disease progression, unacceptable toxicity, or death.
At the 2020 World Lung Cancer Conference (January 2021), the latest exploratory OS analysis of PD-L1 high (TC3 or IC3) WT population showed that OS continued to benefit at a median follow-up of 31.
Tecentriq has shown clinically significant benefits in the treatment of various types of lung cancer.
Tecentriq is approved in the United States, the European Union and other countries in the world.
Reference source: Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer