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news.Roche has received positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), for use of Tarceva (erlotinib) as a maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) and stable disease (cancer remains largely unchanged) after initial chemotherapy.
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Roche said that the CHMP positive opinion clears the way for EU approval and means that this group of patients may soon be able to benefit from earlier treatment with Tarceva.
Reportedly, CHMP positive opinion is based on data from the pivotal Phase III Saturn trial. Saturn showed that Tarceva given as maintenance therapy early after first-line chemotherapy helped delay disease progression (PFS) and extended overall survival (OS) compared to placebo in a broad range of advanced NSCLC patients.
The Phase III Saturn trial was a global multicentre, double-blind, randomised, prospective study to evaluate the efficacy of Tarceva compared to placebo in patients with advanced, recurrent or metastatic NSCLC whose disease had not progressed following first line platinum-based chemotherapy.
The study involved more than 880 patients from approximately 160 centres; 438 received Tarceva and 451 placebo. It showed a positive improvement in both PFS and OS for Tarceva recipients compared to placebo.
The company said that the statistically positive improvement in both PFS and OS demonstrated in the group of patients with SD was greater than that shown in the overall population. Data for patients with SD will be presented at a forthcoming scientific meeting.
In the trial, the patients with stable disease (SD) had a more pronounced OS benefit when Tarceva maintenance therapy was given.
Federico Cappuzzo, principal investigator of the Saturn trial, said: “By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we can help more patients live longer without their disease getting worse.”
Tarceva is already approved in the EU for the second-line treatment of patients with advanced NSCLC.