FDA Approved Rybrevant to Treat Non-Small Cell Lung Cancer

WHO – The US Food and Drug Administration (FDA) approved Rybrevant (Amivanthamb-vmjw) on 21 May, as the primary treatment for adult patients with non-small cell lung cancer, whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) ) Exon 20 insertion mutation. The FDA also approved Guardant360 CDx (Guardant Health Inc.) as a collaborative diagnosis for Rybrevant.

Julia Beaver, M.D., 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, said, “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”.  She further added, “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”.

According to the American Cancer Society, lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer accounting for 80% to 85% of all lung cancers. Approximately 2% to 3% of patients with non-small cell lung cancer will have the EGFR exon 20 insertion mutations, a group of mutations on proteins that cause rapid cell growth, and consequently, help in spreading cancer. EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.

The most common side effects of Rybrevant include rash, infusion reactions, skin infections around fingernails or toes, pain in muscles and joints, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting, and changes in some blood tests.

If patients develop symptoms of interstitial lung disease and are discontinued permanently when the interstitial lung disease is confirmed, then Rybrevant should be stopped. Patients taking Rybrevant should limit sun exposure during treatment and up to two months after treatment. Rybrevant can also harm the fetus when given to a pregnant woman; Therefore, the pregnancy status of women with fertility must be confirmed before starting treatment.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved Rybrevant to treat non-small cell lung cancer with EGFR exon 20 insertion mutations.

The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent presentation and review of oncology drugs among international partners. For this review, the FDA collaborated with the Brazilian Health Regulatory Agency and the Medicines and Health Care Products Regulatory Agency of the United Kingdom. Applications are under review at other regulatory agencies.