FDA Approves Amivantamab for EGFR Exon 20–Positive NSCLC

The FDA has approved amivantamab-vmjw (Rybrevant) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) who harbor EGFR exon 20 insertion mutations.

The regulatory agency also gave the green light to Guardant360 CDx, developed by Guardant Health Inc., for use as a companion diagnostic for the drug.

Amivantamab has been examined in a study that enrolled 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease had progressed either on, or after, platinum-based chemotherapy. Results indicated the the agent elicited an overall response rate of 40% in this population, with a median duration of response (DOR) of 11.1 months. Notably, 63% of patients experienced a DOR that persisted for 6 months or longer.

"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," Julia Beaver, MD, 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, stated in a press release. "With today's approval, for the first time, patients with NSCLC with EGFR exon 20 insertion mutations will have a targeted treatment option."

The most frequently reported adverse effects with amivantamab include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests.

According to the FDA, the agent should be withheld if patients develop symptoms of interstitial lung disease (ILD); it should be permanently discontinued upon confirmation of ILD.

Moreover, patients who are receiving amivantamab should limit sun exposure during, and for 2 months following, treatment. The agent possesses the potential to cause vision issues; it can also cause fetal harm when given to a pregnant woman; as such, the pregnancy status of women of reproductive potential should be confirmed before treatment initiation.

Reference

FDA approves first targeted therapy for subset of non-small cell lung cancer. News release. FDA. May 21, 2021. Accessed May 21, 2021. https://prn.to/3hOrU1t