MANILA, Philippines - Research-based pharmaceutical company AstraZeneca’s targeted cancer therapy gefitinib has received approval from the Philippine Food and Drug Administration (FDA) as first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).
Gefitinib is the first and only approved once-a-day, oral targeted monotherapy that is proven to be more effective than doublet chemotherapy (carboplatin/paclitaxel) as first-line treatment for advanced NSCLC patients with EGFR mutations.
“AstraZeneca welcomes the regulatory approval of gefitinib as first-line treatment, which will provide Filipino lung cancer patients with a more effective, convenient and better-tolerated alternative to chemotherapy, resulting in longer progression-free survival and improved quality of life,” said Amal Kelshikar, president of AstraZeneca Philippines.
The NSCLC is the most common form of lung cancer, accounting for 85 percent of cases. EGFR stands for epidermal growth factor receptor, a type of protein found on the surface of cells to which proteins such as epidermal growth factor (EGF) bind under normal conditions.
In some patients with NSCLC, the EGFR gene can have mutations that cause the EGFR to be permanently activated, which in turn activates another protein, the tyrosine kinase (TKI) enzyme, triggering reactions that cause cancer cells to grow and multiply.
Patients with these mutations are considered to have the EGFR mutation-positive NSCLC. Gefitinib is a pill that targets and blocks the activity of the TKI enzyme, thus preventing cancer cells to grow and multiply.
The approval of the Philippine FDA was based on results of the landmark Iressa Pan-ASia Study (IPASS), which involved 1,217 patients from Asia, with 58 Filipinos, with advanced NSCLC but had not received prior treatment.
The patients’ lung tumors were of the adenocarcinoma type. They had either never smoked or were former light smokers (ceased smoking at least 15 years ago and had 10 pack-years exposure or less).
The IPASS showed that gefitinib had superior efficacy in delaying the progression of the disease, better tolerability and resulted in better quality of life compared to standard doublet chemotherapy with carboplatin and paclitaxel as first-line treatment for EGFR mutation-positive advanced NSCLC.
“The results of IPASS are very important because up to 30 percent of all lung cancer patients in Asia are non-smokers and a significant number are EGFR mutation positive. This study will change the paradigm of first-line lung cancer treatment in Asia,” said Dr. Gerardo Cornelio, past president of the Philippine Society of Medical Oncology, consultant medical oncologist at the University of the Philippines-Philippine General Hospital and chairman of the Department of Medicine of San Juan de Dios Hospital.
Aside from IPASS, there has also been several published clinical studies that show evidence to support TKI as first-line treatment in EGFR mutation positive NSCLC.
“Lung cancer patients should be tested to determine their EGFR mutation status and whether they will benefit from targeted therapies such as gefitinib,” said Dr. Pathmanathan Rajadurai, senior consultant pathologist at Sime Darby Medical Center in Subang Jaya, Malaysia and honorary consultant in pathology at the Malaya Medical Center in Kuala Lumpur, Malaysia.
In the Philippines, EGFR mutation testing is available at St. Luke’s Medical Center, Ambica Biotechnologies, and Complete Solutions.
Cornelio and Rajadurai were the keynote speakers during the launch of the newly approved indication for first-line use of gefitinib last Oct. 21 at the Edsa Shangri-La Hotel in Mandaluyong City.
Entitled “Think 1st, Think Positive: Revolutionizing Breakthrough in 1st-line Lung Cancer Treatment,” the launch was attended by the country’s leading cancer specialists.
2005 data show that lung cancer is the most common cause of death from cancer in the Philippines, followed by liver cancer, breast cancer, colorectal cancer, leukemia, and stomach cancer.