News & Information | START In The News

April 25th, 2013
By: Jim Forsyth

Melanoma Drug, First Tested at San Antonio's START Center, Granted 'Breakthrough' Status

The U.S. Food and Drug Administration has granted 'breakthrough' status to a  melanoma drug first tested at START, putting it on the fast track for approval, 1200 WOAI news reports.

 Dr. Amita Patnaik of the START Center, the state's leading cancer research and treatment practice, says the drug, called lambrolizumab, was treated on 34 San Antonio cancer patients with success.

 "17 patients were treated demonstrated success, with three patients going on to have complete disappearance," she said.

 The drug is being marketed by Merck and Company, and Merck said the FDA's designation of 'breakthrough' status, indicating a drug it things has good potential to make a major difference in the lives of melanoma patients, will allow regulators to take steps to be on the market as soon as possible.

 "Basically, this is an inhibitor of an important mechanism that tumors can use to suppress the immune system," she said.

 The drug is one of a number of what are called 'targeted therapies' which researchers at the START Center and elsewhere are optimistic can 'zero in' on specific infected cells, without the dangerous and debilitating side effects of radiation and chemotherapy.

 Across all Phase I testing, Merck says about half of the patients reported tumor shrinkage after treatment with the drug, and about 10% had no detectable cancer after treatment as assessed by imaging techniques.  That is in line with the START study results.

 Officials aren't sure exactly how long it will take for the drug to be in doctors' offices, Patnaik says, "but we expect the approvals process to be expedited and the time to be shortened to months instead of years."

 Melanoma causes about 75% of the skin cancer deaths in the U.S.  It is caused by damage to DNA inside cells and is usually triggered by damage from UV light from the sun.  Indications of a promising drug to fight melanoma is good news, because the disease has proven highly resilient to traditional forms of treatment.