Debbie Davis, our Executive Administrative Assistant and breast cancer survivor, recently spoke in front of an FDA-convened panel of experts in Washington, DC concerning approval of a new drug for breast cancer. The drug, neratinib, was developed by Puma Biotechnology. The panel voted 12 to 4 to approve it.
Debbie has been on neratinib since March 2016 for compassionate use. She has had breast cancer for 24 years; 17 years at stage IV.
The drug was tested to see if it would prevent breast cancer from recurring in women whose tumors test positive for a receptor called HER2, which completely reflects Debbie. Puma paid for her trip.
In this big clinical trial, it reduced the rate of breast cancer recurrence within 2 years by one-third, but that means it only reduced the absolute number of cases by about 2 per 100 women.
The drug does have side effects: 95% of patients had diarrhea, which was serious for 40%. The benefit, however, was far more pronounced (about double!) in patients whose tumors tested positive for both HER2 and the estrogen receptor (ER+).
Some panelists thought the use of the drug should be limited to women who have taken the breast cancer drug Herceptin within the past 2 years. A few also thought use might be limited to women whose tumors tested ER+.
Many others, including Debbie, argued that they wanted the option. “We should all have that choice,” Debbie insists. Touching stories were told of the medicine being used to treat cancer that has spread throughout the body, not just recurrence after treatment.
Honored to be asked to speak on behalf of neratinib by Puma, Debbie said the 12–4 approval of the drug by the FDA-convened panel of experts gives hope to many who have this type of breast cancer. “Just knowing that there are new drugs out there relieves the anxiety of having cancer, and I was glad to be a small part of that,” Debbie admits.
“One of the best parts of the experience was actually going to the FDA and meeting the other 10 speakers,” Debbie says. “I was surprised by the fact that a few of the scientists from Puma actually knew who I was due to my long survival and good experience on their drug.”
Debbie now feels confident that she can survive anything. “The fact that I have survived cancer for so many years has made me a stronger person,” she explains.
The FDA does not have to follow the recommendations of its panelists, but usually does.
SDI’s Debbie Davis is out there getting medicinal breast cancer progress officially accepted!