Afatinib (Gilotrif), a new drug for the treatment of some lung cancers, will become commercially available in the U.S. beginning the week of September 2. Gilotrif is approved as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have certain mutations in the EGFR gene. A companion diagnostic, the therascreen EGFR RGQ PCR Kit, can detect these specific EGFR mutations, so-called exon 19 deletions or exon 21 (L858R) substitutions. The makers of the drug will offer a patient support program to provide financial and other support to help patients who might otherwise not have access to Gilotrif.
The UK’s National Institute for Health and Clinical Excellence (NICE) has released a guidance document specifying which tests it recommends for detecting mutations of the EGFR gene in non-small cell lung cancer (NSCLC) patients. Patients with EGFR mutations usually benefit more from treatment with EGFR inhibitors rather than traditional chemotherapy, while these drugs are less effective in patients without such mutations. Accurate detection of EGFR mutations is therefore very important. NICE recommends the therascreen EGFR RGQ PCR Kit, the cobas EGFR mutation test, Sanger sequencing of samples, or combined approaches that use Sanger sequencing for samples with more than 30% tumor cells, and one of the two other tests for samples with lower tumor cell density.
Based on the positive results of a recent clinical trial, the FDA approved afatinib for first-line treatment of patients with late-stage, non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. The drug, which will be marketed under the name Gilotrif, is specifically intended for patients with two particular EGFR mutations: exon 19 deletion and exon 21 L858R substitution. The FDA also approved the therascreen EGFR RGQ PCR Kit, a companion diagnostic used to test for EGFR mutations. Afatinib differs from other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa) in that it irreversibly destroys the EGFR protein, instead of just reversibly blocking it, and also inhibits several other related proteins.