Henry Ford Neurosurgeon’s Testimony Aides FDA Approval Process for New Glioma Surgery Drug

June 09, 2017

Detroit – The U.S. Food and Drug Administration approved Gleolan (aminolevulinic acid hydrochloride, ALA HCI), also referred to as 5-ALA, this week, after testimony from two neurosurgeons, including the chair of neurosurgery for Henry Ford Health System.

5-ALA is an optical imaging agent that highlights tumor cells, making them easier for surgeons to see during resection surgery. Patients drink the special dye a few hours before their procedure and the Gleolan compound turns their tumor cells a neon pink. When illuminated with a specialized blue light at a particular wavelength, the bright pink tumor cells are very distinguishable from the normal, healthy cells.

“Even with the most modern technology, it is often difficult for surgeons to determine if they have removed all of the tumor, especially with gliomas,” said Steven Kalkanis, M.D., chairman of neurosurgery at Henry Ford Health System and director of the Henry Ford Cancer Institute. “Glioblastomas tend to have ‘finger-like’ projections that extend into different parts of the brain. This 5-ALA dye makes those tiny projections more visible.”

In the initial randomized, controlled clinical trial performed in the U.S., patients who were given 5-ALA before surgery had twice the rate of survival without progression after six months, compared to patients who didn’t receive the dye. Henry Ford participated in the final clinical trial, propelling the compound toward FDA approval.

Dr. Kalkanis testified before the FDA in Washington, DC this week, alongside his colleague from Mt. Sinai, the lead institution in the U.S. clinical trial process. “We were honored to partner with Mt. Sinai to get this compound approved,” said Kalkanis. “We are living in one of the most hopeful and exciting times for brain cancer treatment and research and 5-ALA will be a wonderful new addition to the tools and technology we have.”

Henry Ford will be among the first hospitals to offer 5-ALA to patients. It’s expected to become available sometime this fall.

MEDIA CONTACT:  

Brenda D. Craig

Director, Media Relations
Henry Ford Health System
bcraig3@hfhs.org