Roche's lung cancer drug receives positive opinion in Europe

CEBU, Philippines - Roche recently announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for use of 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.

The CHMP positive opinion clears the way for European Union approval and means that this group of patients may soon be able to benefit from earlier treatment with erlotinib.

“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of many patients deteriorates rapidly. By giving erlotinib earlier after chemotherapy, instead of waiting for the disease to progress, we can help more patients live longer without their disease getting worse,” said Professor Federico Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital, Italy and principal investigator of the SATURN trial.

The CHMP positive opinion is based on data from the pivotal phase III SATURN trial. SATURN showed that erlotinib 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. 

 Patients with stable disease had a more pronounced OS benefit when erlotinib maintenance therapy was given.

 This new approach to treatment would therefore offer these patients, whose cancer can often progress rapidly, a new and effective oral option to continue treating their disease.

 Erlotinib is already approved in the EU for the second-line treatment of patients with advanced NSCLC.   (FREEMAN NEWS)