May 15, 2013 | By Márcio Barra
Roche, the Swiss cancer drug giant, won the FDA’s Office of In Vitro Diagnostics and Radiological Health approval to sell a companion gene mutation test, that can predict how patients will respond to Tarceva (Erlotinib hydrochloride), a popular treatment for non-small lung cancer.
The diagnostic test, called the Cobas EGFR Mutation Test, detects epidermal growth factor receptor (EGFR) gene mutations, and it’s the first of its kind approved by the FDA. The Cobas EGFR Mutation Test identifies exon 19 deletions or exon 21 substitution mutations in the EGFR gene in a patient DNA.
Tarceva is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR), a receptor highly expressed in various forms of cancer, and it’s sold by Roche and Astellas Pharma US. Tarceva is approved for people with advanced-stage non-small cell lung cancer whose cancer has not grown after initial treatment with chemotherapy of after receiving at least one chemotherapy regimen. The Cobas diagnostic test is being approved alongside an expanded use for Tarceva as a first-line treatment for patients with non-small cell lung cancer that has spread to the rest of the body, and who have the gene mutation that Cobas detects. Tarceva’s new approval follows the successful completion of the EURTAC (European Randomized Trial of Tarceva versus Chemotherapy) clinical trial, where the Cobas Test was employed.