The Oncology Drug Development Process

Jo Anne Zujewski, MD, head, breast cancer therapeutics, cancer therapy evaluation program, National Cancer Institute, discusses the FDA approval process for oncology drugs.

Jo Anne Zujewski, MD, head, breast cancer therapeutics, cancer therapy evaluation program, National Cancer Institute, discusses the FDA approval process for oncology drugs.

Patients want "more, better, faster" in regards to FDA-approved oncology drugs, Zujewski says.Any delay is a disadvantage to patients. Zujewski says she is in favor of international collaborations and standardization of information to ease the process.

Clinical Pearls

Some advances that have been made have been in part due to retrospectively-collected data sets. Going forward, Zujewski says, trials should be developed that have the capacity for retrospective data collection so that, with diagnostic developers, the timeline for approval can be accelerated.

  • Any approval delay is a disadvantage to patients
  • International collaborations and standardization of information and data can aid the process
  • Retrospectively collected data sets can help a drug to advance