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Gilotrif® Approved for Recurrent Squamous Cell Lung Cancer

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The United States Food and Drug Administration (FDA) has approved Gilotrif (afatinib) for the treatment of recurrent squamous cell lung cancer.

The approval is indicated specifically for patients with advanced squamous cell, non-small cell lung cancer (NSCLC) that has continued to progress following prior therapy with platinum compounds (a class of chemotherapy agents used in standard treatment for this type of cancer).


Afatinib is already approved as initial treatment for patients with advanced non-squamous cell NSCLC with the epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.


Lung cancer remains the leading cause of cancer-related deaths worldwide. Lung cancer is divided into subgroups, depending upon the type of cell from which the cancer originates within the lung. As research regarding cancer treatment continues to evolve, novel agents and treatment strategies are focused on targeting very specific genetic mutations and/or molecular markers of cancer cells, ultimately individualizing therapy for every patient.


NSCLC comprises between 75-80% of all lung cancers. Twenty to thirty percent of all NSCLC is squamous cell lung cancer, representing the second largest sub-type, behind non-squamous cell, of NSCLC. Squamous cell NSCLC is associated with a poor prognosis, with a median overall survival in its advanced stages of approximately one year. Therefore, a significant need remains in improved treatment strategies for this type of lung cancer.


The latest approval of afatinib was based on results from the LUX-Lung 8 trial, which included patients with advanced squamous cell NSCLC that had progressed following prior treatment with chemotherapy. One group of patients was treated with afatinib, while a second group was treated with Tarceva (erlotiib). Results from the two treatment groups were directly compared.


• The risk of cancer progression was reduced by 18% among the group of patients treated with afatinib, compared to those treated with erlotinib.
• Disease control (stabilization or regression of cancer) occurred in 51% of patients treated with afatinib, compared with 40% of patients treated with erlotinib.
• The risk of death was reduced by 19% among patients treated with afatinib compared to those treated with erlotinib.
• The most common side effects associated with afatinib were diarrhea, skin rash or acne and mouth sores.

Patients with advanced squamous cell NSCLC that has progressed following prior therapy may wish to speak with their healthcare provider regarding all available treatment options, including afatinib.


Reference: Boehringer-Ingelheim. FDA approves Gilotrif® (afatinib) as new oral treatment option for patients with squamous cell carcinoma of the lung. Available at: http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/4-15-2016-fda-approves-gilotrif-afatinib-oral-treatment-option-patients-squamous-cell-carcinoma-lung.html. Accessed April 21, 2016.