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.