Darlene Gant: Drug company gives unapproved cancer drug after video plea
A 46-year-old Florida woman dying of advanced-stage breast cancer has been given a drug that could prolong her life after making an emotional plea in a YouTube video.
In the video, Darlene Gant desperately begs the Food and Drug Administration and a drug manufacturer, Genentech, to issue her an experimental drug she thinks could improve her prognosis.
"[T]here is a very promising drug for me, pertuzumab, that the FDA is just sitting on since December and does not plan on releasing it until June 2012," Darlene Gant wrote on the page for her video.
Genentech has agreed to issue the drug to Gant, a wife and mother of an 11-year-old son, on what's called "a compassionate basis" after receiving letters from those Gant reached through social media websites like Facebook.
Pertuzumab, a new breast cancer biotechnology drug for patients with advanced HER2-positive disease, will become available in June at the earliest.
In drug trials, patients who added pertuzumab to another drug regimen lived an average of 18.5 months without tumor growth and showed a 38 percent drop in the risk of their disease worsening.
Other patients can apply for "compassionate use" of a drug if it's unapproved, but the process to obtain the drug is lengthy, and some drug companies have strict policies against it.
Pertuzumab is on priority review status with the FDA, which means the drug review can be completed within six months instead of the usual 10 months to 12 months.