publication date: Dec. 6, 2019

Drugs & Targets

FDA approves Tecentriq + chemo as initial treatment metastatic non-squamous NSCLC indication

FDA has approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

Genentech, a member of the Roche Group, sponsors Tecentriq.

This approval is based on results from the phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival = 18.6 versus 13.9 months; hazard ratio = 0.80; 95% CI: 0.64–0.99; p=0.0384) in the intention-to-treat wild-type population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.63–0.91; p=0.0024) in the ITT-WT population.

Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

In lung cancer, Tecentriq is also approved in combination with Avastin (bevacizumab), paclitaxel and carboplatin, 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 disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer.

 

Continue reading FDA approves Tecentriq + chemo as initial treatment metastatic non-squamous NSCLC indication

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