SPUTNIKNEWS – June 13, 2017: The US Food and Drug Administration (FDA) has approved cancer treatment drug Keytruda for all types of cancer carrying a specific genetic feature, or biomarker, even before the treatment had passed all standard testing.
The federal agency in charge of protecting public health through the regulation of consumable consumer products has approved pembrolizumab, which goes under the brand name Keytruda, for the treatment of a wide range of cancers, following a short study in which 86 patients showed very promising results.
This is the first time in history the FDA has approved a drug based not on its effect on a specific tissue, but based on its effect on a specific genetic sequence.
“Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers,” said Richard Pazdur, acting director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
“To finally see now proof that targeting the immune system improves the situation and doesn’t necessarily correlate with one specific cancer… that’s a really powerful message,” says Dr. Jack Jacoub, a medical oncologist and director of thoracic oncology at MemorialCare Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, California. Link: Read Complete Article