Not Hair Loss News – FDA Approves Late-Stage Lung Cancer Drug
From the news release:
The U.S. Food and Drug Administration today approved Gilotrif (afatinib) 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.
Lung cancer is the leading cause of cancer-related death among men and women. 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 percent of lung cancers are NSCLC, making it the most common type of lung cancer. EGFR gene mutations are present in about 10 percent 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 tumors 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.
Read the rest — FDA approves new treatment for a type of late-stage lung cancer
Participants receiving this drug had a delay in tumor growth that was over 4 months later than those receiving chemotherapy. The press release notes that there was “no statistically significant difference in overall survival” though.
This drug approval seems surprising to me. With no difference in overall survival between patients receiving this new drug (afatinib) compared with the control group (pemetrexed and cisplatin), the median difference in progression-free survival (the length of time that the cancer does not progress) was 11.1 months versus 6.9 months (i.e., 4.2 months) in favor of afatinib. Given that the most common drug-related adverse events observed with afatinib were diarrhea (96%), rash/dermatitis (90%), and mouth sores (71%), it’s tough for me to see this as any significant “breakthroughâ€. People don’t survive longer with this drug (compared with standard therapy) but have a median (50% above, 50% below) 4 months of lifetime without disease progression compared with standard therapy but with quality of life that seems impacted. I wish there were new drugs that improved overall survival for these horrible diseases and maintained a good quality of life.