FDA Approves Rybrevant for Certain Patients with Non-Small Cell Lung Cancer

Non-Small-Cell Lung Cancer (NSCLC)Lung cancer is a complex disease, accounting for almost 25% of all cancer deaths. The Food and Drug Administration (FDA) has approved Rybrevant for treatment of adults with non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This approval marks the first targeted treatment option available to this patient population. Rybrevant is a the first fully-human, bispecific antibody approved for NSCLC patients that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation. Among 81 patients with NSCLC and an EGFR exon 20 insertion mutation whose disease had progressed on or after platinum-based chemotherapy, this treatment with Rybrevant induced response rate of 40%. Also, 63% of the participants experienced response to therapy for at least six months. The median duration of response was 11.1 months.

The common side effects associated with Rybrevant treatment included rash, skin infections around the toenails or fingernails, fatigue, sores in mouth, constipation, cough, vomiting etc. Patients taking Rybrevant should limit their sun exposure during and for two months after the treatment. It can also cause fetal harm on pregnant women. With FDA approval, this is an important development for people living with NSCLC with exon 20 insertion mutations who have had no approved treatment options for lung cancer treatment. Rybrevant received Priority Review and Breakthrough Therapy designation.

Jill Feldman, co-founder of the EGFR Resisters said, “We are excited by the promise this new treatment option brings to people with this particular type of lung cancer and their families.” The approval of Rybrevant, along with the companion diagnostic test, addresses high unmet need in treatment of people with genetically defined NSCLC. FDA as simultaneously approved Guardant Health’s Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with Rybrevant.


The information shared in this blog is for educational purposes only. You should always consult your healthcare practitioner for any health issues.


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