FDA approves Boehringer Ingelheim’s Gilotrif for squamous cell lung cancer

Gilotrif was initially approved in the US in July 2013 to treat epidermal growth factor receptor (EGFR)-positive metastatic non-small cell lung cancer (NSCLC).

It has now been approved to treat patients with advanced SqCC whose disease has progressed following the treatment with platinum-based chemotherapy.

The latest approval was based on results of the LUX-Lung 8 study, which demonstrated improved overall survival and progression-free survival compared to Tarceva (erlotinib) in patients with squamous cell carcinoma of the lung.

In the study, Gilotrif reduced the risk of death by 19% and disease progression by 18% compared with Tarceva.

Last week, the European Commission approved the new indication of Gilotrif. Afatinib is already approved in over 60 countries to treat different types of EGFR mutation-positive NSCLC.

Gilotrif is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as identified by an FDA-approved test.

Boehringer Ingelheim said safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations.

The company noted that Gilotrif can lead to diarrhea and cutaneous reactions, including rash, erythema, and acneiform rash.

Palmar-plantar erythrodysesthesia syndrome was also observed in clinical trials in patients taking Gilotrif.

Image: Gilotrif was initially approved in the US in July 2013 to treat epidermal growth factor receptor (EGFR)-positive metastatic non-small cell lung cancer (NSCLC). Photo: courtesy of zole4/FreeDigitalPhotos.net.