publication date: Feb. 14, 2014
A meeting of the FDA Oncologic Drugs Advisory Committee has become a rare occurrence.
Because cancer drugs are getting better, as are applications for their approval, said Richard Pazdur, director of the FDA Office of Hematology and Oncology Products.
“Drug development is much more focused, and decisions are being made on the basis of understanding the molecular basis of the disease rather than the number of responses observed in an early phase study,” Pazdur said.
Many drugs are vying for expedited approval, and preparations for ODAC would slow down the approval.
“In making a decision regarding whether an ODAC is necessary, we must also balance the timing of the meeting versus an expedited approval,” Pazdur said. “Our office has commonly approved important applications prior to their Prescription Drug User Fee Act goal date.
“This is relatively unique to the oncology office. These approvals have occurred as soon as 2.5 months after receipt of the application.
“ODAC scheduling and preparation can be complicated and takes many months. We must balance the potential information that may be obtained from an ODAC against a delay in approving an important drug for which we have adequate information on safety and efficacy. This is of particular concern when we have a drug that addresses an unmet medical need.”
FDA approvals in oncology and hematology reflect development activity in these therapeutic areas, Pazdur said.
For example, in 2011, FDA approved 30 new molecular entities, of which 11 went through Pazdur’s office. In 2012, the agency approved 39 NMEs, of which 14 went through OHOP. And in … Continue reading 40-07 Are Cancer Drugs Getting Better? FDA’s Richard Pazdur Says “Yes”
To access this members-only content, please log in.
Institutional subscribers, please log in with your IP
If you're not a subscriber why not join today?
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.