HER2 Support Group Forums - View Single Post

runtolive · 04-12-2010, 07:48 PM

http://bcaction.org/index.php?page=l...-fast-tracking

why???

March 23, 2010 - Letter to FDA Opposing TDM-1 Fast-Tracking

March 23, 2010
Richard Pazdur, M.D., F.A.C.P.
Director
Office of Oncology Drug Products
U.S. Food and Drug Administration
richard.pazdur@fda.hhs.gov

RE: Opposition to TDM-1 Fast Track Application

Dear Dr. Pazdur:

As you are no doubt aware, Genentech intends to seek fast track approval of TDM-1 based on the results of a single-armed, Phase II trial.

It is our understanding from the sponsor that the FDA was asked two years ago about what would be required for fast track approval of TDM-1, and that the agency took the position then that a randomized trial would be necessary.

Despite this clear direction from the agency, the company has completed -- and will seek FDA approval based on the results of – one single-armed trial, TDM4374g.

Breast Cancer Action believes, as the FDA does, that only sufficiently large, randomized trials will give us the information we need about drug efficacy and safety. We urge you, in the strongest possible terms, to require the sponsor to submit Phase III data before you consider approval of TDM-1 for breast cancer.

We understand that there is an important unmet medical need for people with advanced breast cancer whose treatment options have run out. We desperately hope that TDM-1 proves to be a beneficial option for these people. But we oppose sacrificing drug approval standards on the altar of hasty access.

As you know, the FDA used to require the results from two Phase III trials before considering approval of a drug for the market. More recently, a single randomized trial has been found by the agency to be sufficient in some cases. We think this weakens standards for drug approval. Please do not weaken them further by allowing marketing based on a small, single-armed Phase II trial.

We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial.

The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market,

Sincerely,

Barbara A. Brenner
Executive Director

Note: As a matter of policy, in order to avoid the fact or appearance of a conflict of interest, Breast Cancer Action does not accept funding from Genentech or from any other pharmaceutical or biotech company.

04-12-2010, 07:48 PM	#1
runtolive Senior Member Join Date: Nov 2007 Posts: 210	BCA fighting to keep tdm1 off market http://bcaction.org/index.php?page=l...-fast-tracking why??? March 23, 2010 - Letter to FDA Opposing TDM-1 Fast-Tracking March 23, 2010 Richard Pazdur, M.D., F.A.C.P. Director Office of Oncology Drug Products U.S. Food and Drug Administration richard.pazdur@fda.hhs.gov RE: Opposition to TDM-1 Fast Track Application Dear Dr. Pazdur: As you are no doubt aware, Genentech intends to seek fast track approval of TDM-1 based on the results of a single-armed, Phase II trial. It is our understanding from the sponsor that the FDA was asked two years ago about what would be required for fast track approval of TDM-1, and that the agency took the position then that a randomized trial would be necessary. Despite this clear direction from the agency, the company has completed -- and will seek FDA approval based on the results of – one single-armed trial, TDM4374g. Breast Cancer Action believes, as the FDA does, that only sufficiently large, randomized trials will give us the information we need about drug efficacy and safety. We urge you, in the strongest possible terms, to require the sponsor to submit Phase III data before you consider approval of TDM-1 for breast cancer. We understand that there is an important unmet medical need for people with advanced breast cancer whose treatment options have run out. We desperately hope that TDM-1 proves to be a beneficial option for these people. But we oppose sacrificing drug approval standards on the altar of hasty access. As you know, the FDA used to require the results from two Phase III trials before considering approval of a drug for the market. More recently, a single randomized trial has been found by the agency to be sufficient in some cases. We think this weakens standards for drug approval. Please do not weaken them further by allowing marketing based on a small, single-armed Phase II trial. We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial. The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market, Sincerely, Barbara A. Brenner Executive Director Note: As a matter of policy, in order to avoid the fact or appearance of a conflict of interest, Breast Cancer Action does not accept funding from Genentech or from any other pharmaceutical or biotech company.