TDM-1 is all over the news today as the new “SMART BOMB” in the war against Her2 Breast Cancer. What the Public DOES NOT KNOW is that TWO YEARS after these results were made known the FDA continues to deny access to Stage IV cancer patients. We are asking the FDA to approve TDM-1 now and give these people a chance to live!
We are survivors and caregivers battling an aggressive type of breast cancer known as Her2. Her2 is a mutated gene, first identified in the 1980's. This mutated gene accounts for about two-thirds of the most aggressive breast cancers. A drug that targeted that gene, and shut it off, Herceptin, was developed in the 1990's. It was, and is, a revolutionary drug. It cures some women, and when combined with chemo, cures more. However, some women with Her2 seem to have yet unidentified mutations that Herceptin, with or without traditional chemo, cannot stop.
In 2010, the maker of Herceptin succeeded in attaching a chemo-like toxin to Herceptin called Herceptin T DM-1. Like a "heat-seeking missile" the toxin rides the Herceptin to only the mutated cells and blows them up. Herceptin T DM-1 is a breakthrough drug that has some of the best stats ever for a cancer drug. It is more effective with metastatic Her2 cancers, and has FEWER side-effects! Yet, on September 1, 2010, the FDA blocked its approval. No one knows why, and they are not required to give an explanation. TWO YEARS LATER and the FDA continues to deny access to this life-saving drug!
Support Right to Try Laws
Our Rebuttal to the Right To Try Opposition
Where It All Started: This FDA Revoked Avastin in 2009
See Christi Turnages' testimony, how Avastin / Taxol saved her life, and thousands of other Triple Negative Breast Cancer Survivors across the Country! This FDA ignored her, and dozens of Stage IV Survivors' testimonies. Christi is now 3 and a 1/2 years CANCER -FREE! This same FDA then rejected Herceptin T DM-1 for Early Approval, because they were angry at the same company that produced both life-saving medicines! They cannot be trusted to make "scientific", un-biased decisions about life-saving cancer drugs. We want an Investigation!
SUPPORT THIS CAUSE
- Contact Mr. Craig Handzlik at Goldwater Institute, firstname.lastname@example.org .
- Volunteer to work on Right To Try laws in your State.
- Contact your Legislators.
- Tell your Stage IV Story in person.
- Contact your Congressional Representatives, especially if your U.S. Senators are on the HELP Committee, overseeing this FDA. Tell them to cut FDA red tape. Stop the FDA from delaying compassionate use. Tell them to really PUSH the FDA and the companies to give more expanded access and compassionate use to the most promising drugs as they near approval. The so-called "Breakthrough " status drugs are still TOO SLOW!