publication date: Mar. 22, 2019

Drugs & Targets Tecentriq + chemo gets FDA approval in extensive-stage SCLC

FDA approved Tecentriq (atezolizumab), in combination with carboplatin and etoposide, for the initial treatment of adults with extensive-stage small cell lung cancer.

Tecentriq is sponsored by Genentech, a unit of Roche.

This approval is based on results from the phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival = 12.3 versus 10.3 months; hazard ratio = 0.70, 95 percent CI: 0.54-0.91; p=0.0069) in the intention-to-treat population.

The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival) compared to chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95 percent CI: 0.62-0.96; p=0.017). Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

Results from the phase III IMpower133 study were simultaneously presented at the 2018 World Conference on Lung Cancer and published in The New England Journal of Medicine.

Tecentriq is also approved in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have … Continue reading Tecentriq + chemo gets FDA approval in extensive-stage SCLC

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Copyright (c) 2018 The Cancer Letter Inc.