SAN ANTONIO – A cancer drug on trial in San Antonio has been designated as having potential for expedited review by the U.S. Food and Drug Administration.
The FDA has granted abemaciclib, a cyclin-dependent kinase inihibtor oral pill, a "breakthrough therapy" designation, a process to expedite and review of drugs that are intended to treat a serious conditions.
The data compiled by the START center in San Antonio helped lead the FDA to review the findings.
“The designation of breakthrough therapy for an oncology drug is a very important milestone,” said Dr. Amita Patnaik, clinical investigator at START. “What it means is that the data gets reviewed more expedited by the FDA, and there’s a possibility that the drug may be approved an accelerated matter.”
Abemaciclib is an oral pill that prevents the ability of cells to go through the cell cycle in an uncontrolled manner -- essentially halting the growth of cancer.
“The types of patients that will benefit from this treatment would be hormone receptor-positive breast cancer,” Kunka said. “That’s the indication that the FDA has designated that this drug should be used in.”
In April 2014, Sharon Kunka was one of the very few to derive benefits from the drug after her cancer resurfaced in May 2013. At the time, abemaciclib was in the early stages of trial and had yet to be named.
Since then, Kunka is living proof of having a normal and, essentially, cancer-free life.
“There was a period of about six months that I was sick and pretty much incapacitated,” said Kunka. “We do scans every other month and they’ve all been clear, four months into the start of the drug.”
There is no timetable when the FDA will announce their decision based on the data presented.