New FDA-Approved Treatment Option for Lung Cancer Patients

New FDA treatment Option for Lung Cancer Patients
This page was originally published January 24, 2018 and updated March 26, 2024.

New First-Line Therapy for Lung Cancer Patients

A new weapon in the battle against lung cancer has just been approved for use. The Food and Drug Administration has just approved Gilotrif for non-resistant EFGR mutations in lung cancer treatment, making Gilotrif (afatinib) the most comprehensive first-line therapy of tyrosine kinase inhibitor (TKI) for EGFR mutation-positive metastatic non-small cell lung cancer (NSCLC) patients as well as for patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. Some patients with genetic mutations that have constant activation of the epidermal growth factor receptor (EGFR) protein which is associated with uncontrollable cell division and the development and progression of NSCLC. In 10 percent of NSCLC patients, rare mutations have made treating this disease difficult. This approval expands treatment options for those patients.

Senior vice president of Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Sabine Luik, M.D. said: “This approval is a result of our company’s commitment to delivering meaningful treatment advances in areas with high unmet medical need and reflects the tireless efforts of physicians, researchers and patients who participated in our studies.”

The approval comes after successful clinical trials. Physicians can conduct a biomarker test to discover the type of EFGR present which will determine if a patient is eligible to use Gilotrif. This is the first step in integrating Gilotrif into a patient’s treatment.

Discussing the FDA’s approval, Edward Kim, M.D., Levine Cancer Institute, Carolinas HealthCare System said: “The approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population.”

Gilotrif is for patients whose Non-small cell lung cancer (NSCLC):

  • has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s).
  • has spread to other parts of the body (metastatic), and
  • has not been previously treated for metastatic lung cancer


Gilotrif is used to treat people with squamous cell lung cancer that:

  • has spread to other parts of the body, and
  • has been previously treated with chemotherapy that contains platinum.

President and CEO of Lung Cancer Alliance Laurie Fenton Ambrose commented, “This approval is more welcome news for our lung cancer community…These types of advances are helping expand access to treatment options for patients who might benefit from targeted therapies to fight their specific type of lung cancer.”

More Information on Gilotrif

Patients should consult with their physicians about Gilotrif. More information can be found about Gilotrif on Boehringer Ingelheim’s website location here:

Free Financial Help for Lung Cancer Patients

For patients struggling financially, there is help available. Please see the resources we’ve listed here for help with out-of-pocket insurance expenses, prescriptions, and other medical care services for cancer patients:


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1 Comment

  1. The human body is such a complex system; you just have to keep reallocating resoruces towards researching better treatments.
    Seems like a leap forward!

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