Dr. Tendler on Breakthrough Designation for Ibrutinib

Video

Craig L. Tendler, MD, Vice President, Late Development and Global Medical Affairs for Oncology, Janssen Oncology, discusses the importance of ibrutinib's Breakthrough Therapy Designation.

Craig L. Tendler, MD, Vice President, Late Development and Global Medical Affairs for Oncology, Janssen Oncology, discusses the importance of ibrutinib's Breakthrough Therapy Designation.

Ibrutinib is a great example of how this type of legislation can accelerate the development of drugs so they can be administered to patients sooner, Tendler says. At Janssen, a Breakthrough Therapy Designation allows researchers to use additional resources and engage with the FDA on a more frequent basis.

With this legislation, the FDA gives necessary feedback and insight for Janssen to design proper clinical trials and get the drug to patients. This is crucial, Tendler says, as existing evidence suggests that ibrutinib is superior to available therapies.

Related Videos
Ricardo D. Parrondo, MD, hematologist/oncologist, Mayo Clinic
Ilyas Sahin, MD
Raj Singh, MD
Jaime R. Merchán, MD, professor, co-leader, Translational and Clinical Oncology Research Program, director, Phase 1 Clinical Trials Program, Department of Medicine, Division of Medical Oncology, the University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center
Saad J. Kenderian, MB, CHB
Tycel Phillips, MD
Minesh Mehta, MD
Shivaani Kummar, MBBS, FACP, Margaret and Lester DeArmond Endowed Chair of Cancer Research, Professor and Division Head, Division of Hematology/Medical Oncology, Oregon Health & Science University School of Medicine; co-director, Center for Experimental Therapeutics, co-deputy director, Knight Cancer Institute
Andre Goy, MD
Wenxin (Vincent) Xu, MD,