FDA approves new indication for Gilotrif

FDA recently approved a new indication for afatinib (Gilotrif, Boehringer Ingelheim) for patients with squamous cell carcinoma of the lung. The once-daily tablets are now indicated for the treatment of patients with the lung cancer, whose disease has progressed after treatment with platinum-based chemotherapy.

Here are the top 6 facts to know about Gilotrif:

1. The wholesale acquisition cost for a month of therapy with Gilotrif is $6,991.40.

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2. Gilotrif is an antineoplastic agent that works by targeting epidermal growth factor receptor, a cell surface protein that, when bound to its ligand, promotes cell proliferation.

3. The drug was previously approved in the US for the first-line treatment of specific types of EGFR-mutation positive non-small cell lung cancer (NSCLC).

4. FDA’s decision to approve the supplemental new drug application (sNDA) for Gilotrif was based on the results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumors progressed after first-line chemotherapy.

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5. In the LUX-Lung 8 study, treatment with Gilotrif significantly improved overall survival compared to Tarceva (erlotinib), reducing the risk of death by 19% in patients with advanced squamous cell carcinoma (SqCC) of the lung after chemotherapy, according to LUX-Lung 8 clinical trial investigator Shirish Gadgeel, MD, leader of the Thoracic Oncology Multidisciplinary Team at the Karmanos Cancer Center in Detroit, Mich. “Furthermore, afatinib significantly delayed progression of lung cancer (primary end point) by 18%. The overall rate of severe adverse events (< grade 3) was similar between both therapies, with differences observed in the incidence of certain side effects.”

6. The most common adverse reactions associated with the use of Gilotrif include diarrhea, rash or acne, mouth sores, decreased appetite and nausea. 

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