FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

Officials with the FDA have approved amivantamab-vmjw (Rybrevant) as the first treatment for adults with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, according to a press release. Amivantamab-vmjw previously received priority review and Breakthrough Therapy designation from the FDA.

Lung cancer is the leading cause of cancer-related deaths worldwide, with NSCLC accounting for 80% to 85% of these diagnoses. Only 2% to 3% of patients with NSCLC will have EGFR exon 20 insertion mutations, which cause rapid cell growth and thus help cancer spread quickly. The mutations are the third most common type of EGFR mutation.

Investigators evaluated the efficacy of amivantamab-vmjw in 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease had progressed while receiving or after receiving platinum-based chemotherapy. The researchers found an overall response rate of 40% and a median duration of response of 11.1 months, with 63% of patients having a duration of response of 6 months or longer.

Common adverse effects included rash; infusion-related reactions; skin infections around the nails; muscle and joint pain; shortness of breath; nausea; fatigue; swelling in the lower legs, hands, or face; sores in the mouth; cough; constipation; vomiting; and changes in some blood tests. The drug should be withheld if patients develop symptoms of interstitial lung disease and should be permanently discontinued if this lung disease is confirmed.

Patients should also be counseled to limit sun exposure while receiving amivantamab-vmjw and for 2 months following treatment. Furthermore, it may cause vision problems and can cause fetal harm when administered to pregnant women, so pregnancy status should be confirmed before treatment is initiated.

“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 Julia Beaver, MD, chief of medical oncology in the FDA Oncology Center of Excellence, in the press 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.”

REFERENCE

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer [news release]. FDA; May 21, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-subset-non-small-cell-lung-cancer. Accessed May 21, 2021.