New treatment for late stage lung cancer

THE U.S. Food and Drug Administration last week approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumours express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

Lung cancer is the leading cause of cancer-related death among men and women in the United States. According to the National Cancer Institute, an estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease this year. About 85% of lung cancers are NSCLC, making it the most common type of lung cancer. EGFR gene mutations are present in about 10% of NSCLC, with the majority of these gene mutations expressing EGFR exon 19 deletions or exon 21 L858R substitution. 

Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumours express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.

The approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments, said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research.

“Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumours have the EGFR exon 19 deletions or exon 21 L858R substitution mutations,” Dr Pazdur said.

In May, the FDA approved Tarceva (erlotinib) for first-line treatment of patients with NSCLC. Tarceva’s new indication was approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic to identify patients with tumours having the EGFR gene mutations. 

“The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Centre for Devices and Radiological Health.

The FDA’s approval of the therascreen EGFR RGQ PCR Kit is based on data from the clinical study used to support Gilotrif’s approval. Tumour samples from NSCLC participants in the clinical trial helped to validate the test’s use for detecting EGFR mutations in this patient population.

Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumours harboured EGFR mutations. Participants were raNew Balance Laufschuhe und Bekleidung online kaufen