FDA decisions in oncology, cardiology; Virtual AAHPM and other meetings slated

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for Feb. 15-21, 2021. It’s a light week.


  • The FDA’s Circulatory System Devices Advisory Committee will meet virtually on Feb. 17 to review Becton Dickinson/C.R. Bard’s Lutonix 014, a drug-coated balloon, for percutaneously treating obstructed popliteal, tibial, and peroneal arteries.
  • The Cardiovascular Research Technologies (CRT) virtual meeting started on Feb. 13 and is continuing every Friday and Saturday through April 24.

Hospice: The American Academy of Hospice and Palliative Medicine (AAHPM) and the Hospice and Palliative Nurses Association Annual Assembly will be held virtually Feb. 17-19. This is an opportunity to share research, clinical best practices, and practice-related guidance to advance the specialty and improve patient care.

Oncology: The FDA is expected to make a decision by Feb. 15 on G1 Therapeutics’ trilaciclib, an IV CDK4/6 inhibitor with a short half-life, for use as a myelopreservation therapy to help reduce the need for growth factor administration or blood transfusions in small cell lung cancer patients undergoing chemotherapy.


  • The FDA, in conjunction with the Duke-Margolis Center for Health Policy, is hosting a two-day virtual workshop on Feb.16-17 on evaluating real-world evidence (RWE) from observational studies. The meeting will highlight preliminary results from ongoing trial replication efforts to better understand the strengths and limitations of observational studies when considering them to inform regulatory decision-making. The conference will examine the challenges of data adequacy and bias using real-world evidence.
  • On Feb. 18, in honor of Black History Month, the FDA’s Oncology Center of Excellence will host a virtual panel discussion on “Living with Cancer While Black Clinical Trial Barriers, Part Two.”

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 914

Topic ID: 74,914,494,791,730,914,24,192,725