FDA OKs Targeted Lung Cancer Rx

FDA approves Rybrevant (amivantamab-vmjw) to treat non-small cell lung cancer

(RxWiki News) The US Food and Drug Administration (FDA) has approved a targeted drug for a type of non-small cell lung cancer.

This new drug is called Rybrevant (amivantamab-vmjw). The FDA approved it to treat non-small cell lung cancer with tumors that have a certain genetic mutation.

This new approval is part of an effort to provide more precise — and hopefully more effective — treatment of specific subtypes of cancer, the FDA noted.

“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, in a 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.”

Lung cancer is the leading type of cancer and cause of cancer-related death around the world, the FDA reported. Non-small cell lung cancer accounts for the vast majority of lung cancer cases.

Between 2 and 3 percent of patients with non-small cell lung cancer will have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, according to the FDA. These mutations help cancer spread faster.

Rybrevant targets these mutations to treat this type of non-small cell lung cancer. The FDA approved it based on the results of a study of 81 patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. Overall, 40 percent of these patients saw improvement after treatment with Rybrevant. This response lasted for 11.1 months on average, with the response lasting for at least six months in 63 percent of the study patients.

Infusion-related reactions, rash, muscle and joint pain, skin infections around the fingernails and toenails, nausea, vomiting, shortness of breath, mouth sores, constipation, fatigue, cough, changes in certain blood tests and swelling in the lower legs, hands or face were the most commonly reported side effects of Rybrevant. Pregnant women should not take Rybrevant. Patients who take this medication should limit their sun exposure for two months, the FDA said.

The FDA approved this drug for Janssen Pharmaceutical Companies of Johnson & Johnson.

Talk to your health care provider about the best treatment for your condition.

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Review Date: 
May 23, 2021