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


The decision from the Food and Drug Administration marks the first approval of a targeted treatment option for adults with non-small cell lung cancer whose tumors harbor a specific genetic mutation.

The Food and Drug Administration (FDA) on Friday approved Rybrevant (amivantamab-vmjw) for the treatment of adults with non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations, according to a news release from the agency.

Of note, the approval marks the first targeted treatment option available to this patient population.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in the release. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

Although estimates from the American Cancer Society indicate NSCLC accounts for approximately 80% to 85% of all lung cancer cases, only around 2% to 3% of patients have this specific genetic mutation.

Among 81 patients with NSCLC and an EGFR exon 20 insertion mutation whose disease had progressed on or after platinum-based chemotherapy, treatment with Rybrevant induced an overall response rate (percentage of patients who had a complete response or partial response to the therapy) of 40%. Moreover, treatment with the study drug resulted in a median duration response of 11.1 months in all patients. Sixty-three percent of the participants experienced a response to therapy for at least six months.

Some of the more common side effects associated with Rybrevant treatment included, but were not limited to, rash, skin infections around the fingernails or toenails, nausea, fatigue, sores in the mouth, cough, constipation and vomiting. The agency advises that patients who develop signs of interstitial lung disease (ILD) should immediately discontinue treatment and permanently stop treatment with the therapy once ILD is confirmed.

Patients should also limit sun exposure during treatment and for two months after treatment has stopped.

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