Research & Development
Roche wins US FDA approval for Premarket Approval (PMA) supplement for the cobas EGFR Mutation Test v2 for treating metastatic NSCLC
19 April 2018 -

Pharmaceuticals company Roche (SIX:RO)(OTCQX:RHHBY) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for its Premarket Approval (PMA) supplement for the cobas EGFR Mutation Test v2 to be used as a companion diagnostic test (CDx) for first line treatment of patients diagnosed with metastatic NSCLC (non-small cell lung cancer).

The cobas EGFR Mutation Test v2 may be used as a companion diagnostic test (CDx) with TAGRISSO for first line treatment of patients diagnosed with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. TAGRISSO 40mg and 80mg once-daily oral tablets have been approved for 1st-line EGFRm advanced NSCLC and for patients with EGFR T790M mutation-positive advanced NSCLC.

Based on the clinical studies, the company has demonstrated that patients diagnosed with NSCLC who test positive for defined mutations of the epidermal growth factor receptor (EGFR) gene benefit from tyrosine kinase inhibitor (TKI) therapies.

Prior to the new approval, the cobas EGFR Mutation Test v2 was US FDA-approved as a companion diagnostic test with TAGRISSO for second line treatment and beyond in NSCLC patients who test positive for the EGFR T790M mutation, the EGFR exon 19 deletion or L858R sensitising mutations.

According to the company, the EGFR testing in plasma offers a non-invasive option for patients using a simple blood draw for those who are not eligible for a tissue biopsy. In addition, the workflow for cobas EGFR Mutation Test v2 enables patients and clinicians to obtain results in as little as one day.

A number of well-published clinical studies have now demonstrated that the cobas EGFR Mutation Test v2 is a robust and reliable diagnostic test for the detection of defined mutations of the EGFR gene from a tumour tissue biopsy or from plasma and is able to identify those patients most likely to respond to EGFR tyrosine kinase inhibitor (TKI), concluded the company.

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