FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer
Dec 19, 2023
Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first 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 mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today. “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, 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. “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.”
Radiation Oncologists Met With Congressional Leaders to Reverse CMS Cuts and Provide Equal Access to Care
Radiation oncologists met with Congress to urge leaders to consider how the Medicare and Medicaid Services (CMS) proposal to make significant cuts to radiation oncology facilities could be detrimental to the survival of patients with Read more…
FDA Approves Neoadjuvant Pembrolizumab Combination for Early TNBC Indication
The FDA granted approval to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as neoadjuvant therapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) when given in combination with chemotherapy followed by single-agent Read more…
Recommended TVUS Screening Thresholds May Miss Endometrial Cancer in Black Women
Adherence to current clinical guidelines for the evaluation of postmenopausal bleeding may result in systematic underdiagnosis of endometrial cancer (EC) in Black women, according to a study published online July 15 in JAMA Oncology. Kemi M. Read more…