April 26, 2012 -- A mother dying of breast cancer and desperate to get a drug that has yet to be approved by the U.S. Food and Drug Administration appears to have cleared her final hurdle and expects to get her first dose on Friday.
Darlene Gant, 46, of Tampa Bay, Fla., had posted a video plea on YouTube in a campaign to get access to the trial drug known as pertuzumab under compassionate use.
The FDA is expected to approve pertuzumab, developed by Genentech, on June 8. But Gant doesn't expect to live that long.
"In the meantime, no one is eligible for compassionate use, including me, so, although I don't put everything into pertuzumab, it could stabilize me and help save my life and extend my time here on the earth with my 11-year-old son and my family," Gant said in the video.
Gant had won over the Food and Drug Administration and Genentech -- but still faced obstacles involving the Moffitt Cancer Center's Institutional Review Board.
But now, Moffitt's IRB has decided to allow her to start treatment Friday at Moffitt in Tampa, Fla.
The first step will be a large "loading dose" and Gant will be monitored closely in the days ahead for reactions such as rash, breathing difficulties and potential heart issues, she said. The drug also poses a danger to her liver.
But the potential side effects pale in comparison to Gant's prognosis without the drug.
In the self-made video, Gant lay in her bed, too weak to sit up. She held a letter to her son. Beside her were several others: a letter for her son's 12th birthday, two more for his high school and college graduations, another for his wedding day. Gant was writing the letters because she didn't believe she'd be around for the milestones.
Gant initially took aim at the FDA for prohibiting the medication, but she soon realized that FDA had given the green light. It was Genentech Inc. that initially refused her the drug.
Gant said she and family members sent in several requests to obtain the drug before the expected approval date, but the company refused. She implored viewers to write to Genentech to request the drug for compassionate use.
Days after posting the YouTube video, South San Francisco, Calif.-based Genentech agreed to provide the unapproved drug to Darlene for compassionate use.