Astellas has submitted its cancer drug Tarceva to US regulators for approval to treat a genetically distinct form of locally advanced or metastatic non-small cell lung cancer (NSCLC).
The pharma company wants an FDA licence to market Tarceva (erlotinib) as a personalised treatment for patients whose tumours have the epidermal growth factor receptor (EGFR) activating mutations.
This would be detected by an approved test and in support of the supplemental new drug application (sNDA) Astellas’ marketing partner Roche is seeking approval for a companion diagnostic.
Roche’s Cobas EGFR Mutation Test is used to identify people with NSCLC whose tumours have EGFR activating mutations, and it is currently under review by the US Center for Devices and Radiological Health.
It is estimated that as many as one in ten people in Western populations with lung cancer, and three in ten Asian people with lung cancer, have EGFR activating mutations.
They can lead to accelerated cell growth and division and development of metastases, and some NSCLC tumours have activating mutations in the EGFR gene that change the structure of the EGFR proteins so they have increased activity.
The US Tarceva sNDA submission is based on results of the EURTAC trial, a prospective, randomised, controlled phase III trial that compared first-line use of Tarceva against platinum-based chemotherapy in patients with EGFR activating mutation-positive advanced NSCLC.
The trial of 174 predominantly caucasian patients had a primary endpoint of investigator-assessed progression-free survival (PFS) and reflected a total of 133 PFS events. Analysis of these events found a median PFS of 10.4 months in the Tarceva group and 5.1 months in the platinum-based chemotherapy group. Tarceva also reduced the risk of lung cancer getting worse by 66 per cent, Astellas said.
Tarceva, which was first licensed in the US in 2004, was approved for this new indication in Europe last year.
The drug is jointly marketed by Astellas and Roche’s Genentech unit in the US and last year its global sales stood at 1.3bn Swiss francs (about €1bn).