Roche's Genentech unit on Tuesday announced that the FDA cleared the anti PD-L1 cancer immunotherapy Tecentriq (atezolizumab) for use in certain patients with metastatic non-small-cell lung cancer (NSCLC). Specifically, the therapy was approved for patients whose disease progressed during or following platinum-containing chemotherapy, and for patients whose disease progressed on an appropriate FDA-approved targeted therapy if their tumours have EGFR or ALK gene abnormalities.
The drugmaker noted that the approval was supported by results from the Phase III OAK and the Phase II POPLAR trials. Data from the OAK study, unveiled earlier this month, showed that patients who received Tecentriq lived a median 13.8 months, 4.2 months longer than those treated with docetaxel. Roche has previously disclosed that the therapy met the co-primary endpoints of the trial (for related analysis, see ViewPoints: Roche throws curveball with Tecentriq data).
Chief medical officer Sandra Horning remarked "Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy," adding that the therapy "is the first and only approved cancer immunotherapy designed to target the PD-L1 protein."
FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
In April, Tecentriq was awarded priority review by the FDA for the treatment of certain patients with locally advanced or metastatic NSCLC. The drug was also granted breakthrough therapy status for the same indication last year.
Earlier this year, Tecentriq was cleared by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma, marking the first approval of a PD-L1 inhibitor for this indication.
Analysts predict that Tecentriq will generate sales across all cancers of $4 billion in 2021. For additional analysis of PD-L1 inhibitors, read KOL Views: Reassessing the outlook for anti-PD(L)1 drugs – individually and collectively – in NSCLC in the wake of ESMO.
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