April 18, 2018
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Premarket Approval (PMA) supplement for the cobas® EGFR Mutation Test v2 to 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. A companion diagnostic test is a medical device which provides information that is essential for the safe and effective use of a corresponding therapeutic product.
Clinical studies have 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. The cobas® EGFR Mutation Test v2 was previously 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 test is also a companion diagnostic test with Tarceva® (erlotinib) for NSCLC patients who test positive for the EGFR exon 19 deletion or L858R sensitizing mutations.
Approvals thus far are for both tissue and liquid (patient blood plasma) biopsy. 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.
About the cobas® EGFR Mutation Test v2
The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions, and T790M mutations. This in-vitro diagnostic (IVD) test is the first and currently the only FDA-approved EGFR test to include both tissue and liquid biopsy (plasma) as patient sample types for testing. A number of well-published clinical studies such as AURA, AURA2, FLAURA, ENSURE, EURTAC, and FASTACT2, 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). The test is performed on the cobas® 4800 System, which offers high-performance PCR amplification and detection coupled with software that automates result interpretation and reporting.
About TAGRISSO® (osimertinib)
TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. 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 non-small cell lung cancer.
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