FDA approves new treatment for a type of late-stage lung cancer

FDA has approved afatinib (Gilotrif, Boehringer Ingelheim) for patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

“The approval of Gilotrif offers an additional treatment option for this form of lung cancer,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “With increased research to improve our understanding of the origin and progression of this type of lung cancer, it is expected that more effective treatment options will follow suit in the near future.”

Lung cancer is the leading cause of cancer-related death among men and women. An estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease this year, according to the National Cancer Institute. 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. 

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

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

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

Afatinib’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumors harbored EGFR mutations. Participants were randomly assigned to receive afatinib or up to 6 cycles of the chemotherapy drugs pemetrexed and cisplatin.

Participants receiving afatinib had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.

Common side effects of afatinib include diarrhea, skin breakouts that resemble acne, dry skin, pruritus, inflammation of the mouth, paronychia, decreased appetite, decreased weight, cystitis, nose bleed, runny nose, fever, eye inflammation, and hypokalemia. Serious side effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation, and liver toxicity.