FDA Roundup: October 13, 2023

FDA News Release

• For Immediate Release: October 13, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• The FDA Oncology Center of Excellence (OCE) in conjunction with the European Medicines Agency (EMA) will host a Conversations on Cancer public panel discussion October 19, 2023, addressing the experience of living with metastatic breast cancer. The panel will feature speakers with a range of perspectives on breast cancer and, for the first time, will be an international collaboration with our colleagues at the EMA with the hope of highlighting the day-to-day, year-to-year experience of patients living with metastatic breast cancer (https://www.surveymonkey.com/r/SGF5FCP). 
  “The FDA’s Oncology Center of Excellence is excited to join with the EMA for this important discussion on cancer survivorship and the varied global experiences of people living with metastatic breast cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Cancer survivorship continues to be an issue of growing importance that we see highlighted through science-led projects like Cancer Moonshot in the U.S. and the EU beating cancer plan in EU. Given our new collaboration with the EMA, we hope to learn from any commonalities as well as distinctions amongst patients and providers in U.S. and Europe.”
• On Wednesday, the FDA approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested. The most common adverse reactions (≥25%) were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. View full prescribing information for Braftovi and Mektovi.
• On Tuesday, the FDA posted the list of guidance documents it intends to publish Fiscal Year 2024 (FY24). Feedback is critical in shaping CDRH’s guidance development plans. CDRH invites the public to submit comments on any or all the guidance document topics at www.Regulations.gov under docket number FDA-2012-N-1021.
• On Friday, the FDA authorized marketing of the HistoSonics Inc. Edison System for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound. This type of ultrasound generates cavitation, a process in which the static pressure of liquid is reduced below the liquid’s vapor pressure, creating small, vapor-filled cavities without the use of heat. This method differs from high-intensity focused ultrasounds which uses heat to destroy tissue and avoids cavitation. Non-thermal focused ultrasound should only be considered in patients with a sufficient amount of functional liver reserve to withstand the destruction of the planned volume of liver tissue.