Roche lung cancer drug receives FDA approval

MANILA, Philippines - Pharmaceutical company Roche announced this week that the Philippine Food and Drug Administration (FDA) has approved its oral drug erlotinib as first-line therapy for people with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

Based on the primary efficacy result of Optimal Study which is a prospective phase III trial conducted among Asians with EGFR activating mutations, erlotinib nearly tripled the time patients live without their disease progressing (progression free survival or PFS) compared to chemotherapy (13.1 months in the erlotinib arm vs 4.6 months for the chemotherapy arm).

Also, the study reported doubling of the number of patients whose tumors shrink when given erlotinib.

Another phase III trial called EURTAC Study conducted this time among Caucasians, showed similar superior efficacy result of erlotinib versus chemotherapy in terms of progression free survival.

Adverse events were consistent with those observed with previous pivotal trials of erlotinib.

“The Philippine FDA approval for erlotinib is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit and convenience when the medicine is used as an initial treatment,” said Dr. Antonio Villalon, medical oncologist and director of the Cancer Institute of St. Luke’s Medical Center, Global City.

“Advanced lung cancer is often diagnosed with little warning of symptoms and progresses aggressively so it is important to identify which patients may benefit from early treatment with erlotinib,” Villalon added.

Erlotinib is already approved in the Philippines for use in advanced or metastatic NSCLC irrespective of a patient’s EGFR status both as maintenance therapy in patients with stable disease and in patients whose disease has progressed following at least one course of chemotherapy (second- or third-line therapy).

Erlotinib is an oral, non-chemotherapy drug for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers.

According to the World Health Organization, lung cancer is the top cause of cancer-related death. It kills more people than breast, colon, kidney, liver, skin cancer and prostate cancers combined.

In 2008, there were 1.6 million new cases of lung cancer worldwide and each year 1.3 million people die as a result of the disease.

In the Philippines, lung cancer is the most common cancer in men and third most common in women. In the 2010 Cancer Facts and Estimates published by the Philippine Cancer Society, lung cancer is the leading cause of cancer deaths, with 9,184 deaths among both sexes (6,987 males and 2,197 females).