SEP 23, 2021 1:30 PM PDT

The FDA approves the first and only oral treatment for a certain non-small cell lung cancer.

WRITTEN BY: J. Bryce Ortiz

Last week, the United States Food and Drug Administration (FDA) granted approval for the first oral therapy to treat a certain type of difficult-to-treat lung cancer. Lung cancer is the most commonly diagnosed cancer in the world, with over 2 million new diagnoses per year. Additionally, it is the leading cause of cancer-related deaths worldwide. Depending on the severity of the cancer there are various treatment regimens that include surgery, chemotherapy, and radiation therapy. Unfortunately, in some patients the disease continues to progress during or after these treatments. However, recent clinical trials have revealed promising data that the newly approved drug, mobocertinib (Exkivity, Takeda Pharmaceutical Company), can be used to combat treatment resistant lung cancer. 

Mobocertinib was designed to treat a specific type of treatment resistant lung cancer called non-small cell lung cancer (NSCLC). NSCLC is the most prominent form of lung cancers as it comprises around 85% of all lung cancer cases. Because of its high incidence and death rate, NSCLCs have been well studied and many of the genetic changes that lead to this type of lung cancer have been outlined. Among these genetic changes, mutations in a gene called epidermal growth factor receptor (EGFR) are common in NSCLCs. Targeting these mutations to treat or prevent NSCLC has been well studied, but discovering effective treatments for the mutations has proven elusive.  As Pasi A. Jänne, MD, PhD of Dana Farber Cancer Institute said, “EGFR [mutated non-small cell lung cancer] is an underserved cancer that we have been unable to target effectively with traditional [medications].” However, in preclinical and clinical studies, researchers found that mobocertinib works by preventing mutations to the EGFR gene which can help slow the spread of the cancer and the progression of the disease. 

Data presented by Takeda at the 57th American Society of Clinical Oncology Annual meeting provided clinical trial evidence of the effectiveness of mobocertinib in treating NSCLC patients with EGFR mutations. The data show that patients who were treated with the drug showed an improved survivability compared to patients who were treated with different medications. The FDA approved the medication based on these results and the drug is the first and only approved oral therapy that is designed specifically for NSCLC patients with EFGR mutations. The approval of this drugs is important milestone for patients with NSCLC and fulfills a critical need in providing therapy for this difficult-to-treat cancer.


Sources: FDACA: A Cancer Journal for CliniciansTakedaNatureCancer Discovery

About the Author
Doctorate (PhD)
Science and medical writer | Researcher | Interested in the intersection between translational science, drug development, and policy
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