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FDA Approves Afatinib (Gilotrif) for Late-Stage Lung Cancer

Companion test also approved to identify appropriate patients (July 12)

The FDA has given “thumbs up” to 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.

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

Afatinib is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations. In May, the FDA approved erlotinib (Tarceva, Genentech/OSI Pharmaceuticals) for first-line treatment of patients with NSCLC. The new indication for erlotinib 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.

The efficacy and safety of afatinib were established in a clinical study of 345 subjects with metastatic NSCLC whose tumors harbored EGFR mutations. The subjects were randomly assigned to receive afatinib or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin.

Participants receiving afatinib showed 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.

Source: FDA; July 12, 2013.

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