The FDA Priority Review Designation: A Primer

Picture1By Peter Martin, M.D.

Under the Prescription Drug User Act the FDA created a two-tiered system for review of new drug applications (NDA). The first tier of this system, known as Standard Review, is for treatments that offer a minor improvement over existing therapies, and sets the timeline to review at 10 months from receiving the NDA. The second tier, the Priority Review, is for drugs that offer major advances over existing therapies, or provide a treatment where none had previously existed, and reduces the approval timeframe of review to 6 months.

Significant improvements over pre-existing treatments include evidence of increased effectiveness in treatment, prevention, or diagnosis, reduction in treatment-limiting reactions, evidence of safety and effectiveness in a new patient population, and documented enhancement of patient compliance that is thought to lead to an improvement in serious outcomes.

Unlike other expedited approval programs with different levels of standards the Priority Review designation does not change the scientific or medical standards used for approval by the FDA. Instead more resources are devoted to expediting approval for the treatments that receive this designation because the FDA has decided chosen treatments serve a much greater need. To receive the Priority Review designation the FDA requires evidence of increased effectiveness in treatment prevention, or diagnosis of a condition.

Previous Entries in the Primer Series

The FDA Approval Process
The FDA Breakthrough Therapy Designation
THE FDA Accelerated Approval Designation

Dr. John Allan Describes a Clinical Trial for Patients with B-Cell Malignancies

In this video Dr. John Allan describes the benefits of a recently opened clinical trial for men and women with CD20+ B-cell malignancies, including B-NHL and CLL.

If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of B-cell malignancy trials at Weill Cornell Medicine can be found on the Joint Clinical Trials website.

New Clinical Trial: A Phase 1 Study to Assess Safety/Tolerability of REGN1979 & REGN2810 in Patients with B-Cell Malignancies

The Weill Cornell Medicine Lymphoma Program has recently opened a new clinical trial for men and women with B-cell non-Hodgkin lymphoma. The study sponsor is Regeneron Pharmaceuticals, Inc., and the principal investigator at Weill Cornell is Sarah Rutherford, M.D. For more information about the study, please call Rita Gazivoda, RN at 212-746-0702 or e-mail Rita at rig9021@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older with either B-cell non-Hodgkin lymphoma with active disease that is either refractory to or relapsed after most recent prior therapy for whom no standard of care options exist or documented Hodgkin lymphoma with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with lymphoma for whom no standard of care options exist. Currently available treatments for lymphoma are effective in some patients, however, other patients experience relapse or refractory disease following treatment. Therefore, there is a need to find more effective treatments when patients fail to respond to existing standard of care options. Patients will be administered REGN2810 intravenously every 2 weeks at a specified dose level. Patients will receive REGN2810 for a minimum of 12 doses (24 weeks) and up to a maximum of 24 doses (48 weeks). Upon completion of treatment, there will be a 24-week follow-up period. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.