Puma Biotechnology has reached agreement with the U.S. FDA under a Special Protocol Assessment for the planned Phase III clinical trial of the company's lead drug candidate PB272 in patients with HER2-positive metastatic breast cancer who have failed two or more prior treatments. The SPA is a written agreement between the company, as the trial's sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase III trial to be used in support of a New Drug Application for PB272. The European Medicines Agency has also provided follow-on scientific advice consistent with that of the FDA regarding the company's Phase III trial design and endpoints to be used and the ability of such design to support the submission of a European Union Market Authorization Application. Pursuant to the SPA and SA, the Phase III trial will be a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial is expected to enroll approximately 600 patients who will be randomized to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial will be conducted at approximately 150 sites in North America, Europe and Asia-Pacific. The agreed upon co-primary endpoints of the trial are progression-free survival and overall survival. The company plans to use the progression-free survival data from the trial as the basis for submission of an NDA/MAA for Accelerated/Conditional Approval for PB272 from the regulatory agencies. Puma anticipates that it will begin patient enrollment in this Phase III trial in March or April of this year.
- Pharmaceuticals & Drug Trials
- Phase III clinical trial
- metastatic breast cancer