Roche's Tecentriq garners FDA approval for first-line use with chemotherapy in NSCLC

Roche announced Wednesday that the FDA approved Tecentriq (atezolizumab) in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small-cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. The PD-L1 inhibitor gained clearance in this indication in Europe in September.

"We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous NSCLC," remarked Levi Garraway, Roche's head of global product development. Approval is based on findings from the Phase III IMpower130 study, which the drugmaker announced last year met its main goals of overall survival (OS) and progression-free survival (PFS).

Results later detailed at the European Society for Medical Oncology (ESMO) congress showed that median OS was 18.6 months in patients who received Tecentriq plus chemotherapy, which was a significant improvement over 13.9 months seen for chemotherapy alone. Meanwhile, data indicated that patients who received Tecentriq plus chemotherapy had median PFS of 7.2 months, compared to 6.5 months for chemotherapy alone.

Other lung cancer indications for Tecentriq approved in the US include use in combination with Roche's Avastin (bevacizumab) plus chemotherapy for the first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. In addition, the drug is authorised to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, as well as being cleared for use in combination with chemotherapy for the first-line treatment of adults with extensive-stage small-cell lung cancer.

In the third quarter, sales of Tecentriq surged 154% year-over-year to CHF 515 million ($521 million). For related analysis, see KOL Views Results: Leading oncologist separates I/O contenders from pretenders in battle for NSCLC supremacy.

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