FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

Basel, 19 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by June 19, 2020.Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity or death; orCisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein
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