Dr. Tendler on Breakthrough Designation for Ibrutinib

Craig L. Tendler, MD
Published: Wednesday, Jun 26, 2013

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.

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.


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