Roche's liquid biopsy pips Guardant's on companion nods

Friday’s US approval as a companion diagnostic for Amgen’s Kras inhibitor Lumakras is the third such nod for Guardant360 CDx. Guardant’s liquid biopsy can be used to pick out patients with advanced non-small cell lung cancer whose tumours harbour the Kras G12C mutation, thought to be present in around 13% of this population. But Guardant360 CDx is some way behind Roche’s FoundationOne Liquid CDx, approved in the US for no fewer than seven drugs in four different cancers. A look at forecast sales, compiled by Evaluate Pharma, for these targeted therapies gives a loose indication of how the two tests might sell: the drugs with which Roche’s test may be used are forecast to generate $14.5bn of collective revenue in 2026, whereas the corresponding figure for Guardant’s assay is a comparatively paltry $10.8bn. Naturally not all patients with these cancers will respond to these therapies – the Alk arrangements amenable to treatment with Alecensa occur in just 3-7% of advanced NSCLC cases, for instance – but many more patients will undergo liquid biopsy testing.

Liquid biopsy US approvals as companion diagnostics
Test (company) Indication Drug 2021e sales by indication ($m) 2026e sales by indication ($m) Date of test approval as CDx
Guardant360 CDx (Guardant Health) NSCLC Tagrisso 5,355 9,059 Aug 7, 2020
Rybrevant - - May 21, 2021
Lumakras 92 1,756 May 28, 2021
FoundationOne Liquid CDx (Roche) NSCLC Iressa 240 126 Aug 26, 2020
Tagrisso 5,355 9,059 Aug 26, 2020
Tarceva 98 40 Aug 26, 2020
Alecensa 1,707 2,122 Oct 26, 2020
Prostate cancer Rubraca 19 185 Aug 26, 2020
Lynparza 263 1,435 Nov 6, 2020
Ovarian cancer Rubraca 174 419 Oct 26, 2020
Breast cancer Piqray 421 1,114 Oct 26, 2020
SBI = sales by indication. Source: Evaluate Pharma, FDA & company releases. 

This article has been corrected to remove a misattributed approval for FoundationOne Liquid CDx.

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