FDA clears Gilotrif as late stage non-small cell lung cancer therapy

The US Food and Drug Administration (FDA) has cleared Boehringer Ingelheim's tyrosine kinase inhibitor Gilotrif (afatinib) as a new medication for patients with late stage (metastatic) non-small cell lung cancer (NSCLC).

The approval also includes a companion test to identify appropriate patients.

Gilotrif is indicated for NSCLC patients whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by the therascreen EGFR RGQ PCR Kit.

Safety and effectiveness of Gilotrif, which works by blocking proteins believed to promote the development of cancerous cells, was established in a study with 345 NSCLC patients whose tumors harbored EGFR mutations.

The data from the study supported the new medication approval and also formed the basis for the approval of the companion test kit.

US-based Boehringer Ingelheim Pharmaceuticals will market Gilotrif, while the therascreen EGFR RGQ PCR Kit is manufactured by UK-based QIAGEN Manchester.

The FDA Center for Drug Evaluation and Research office of hematology and oncology products director Richard Pazdur said, "Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations."

In May 2013, Tarceva (erlotinib) was cleared as first-line treatment of patients with NSCLC by the US regulator along with a companion diagnostic, the cobas EGFR Mutation Test.

The Roche Molecular Systems manufactures the cobas EGFR Mutation Test and Genentech and OSI Pharmaceuticals jointly markets Tarceva.

Published 16 July 2013

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/

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