FDA moves to clear path for drugs aimed at cancer-causing genes
[...] in a long-awaited move, U.S. drug regulators will simplify the approval of treatments targeting specific gene mutations that can spur tumors in a variety of organs.
The Food and Drug Administration will soon announce a plan to update agency policies and facilitate the approval of critically needed drugs, including those known as tumor-agnostic therapies, which attack cancer-linked DNA, according to FDA Commissioner Scott Gottlieb.
Last month, the FDA approved the first tumor-agnostic drug, expanding the use of Merck’s blockbuster treatment Keytruda to patients with solid tumors that test positive for a certain mutated gene.
“We’ll clarify when we may be able to give a broad approval to a cancer drug, in multiple different kinds of molecularly similar cancers, that’s not particular to the tumor being in any one specific tissue or organ,” he said in his prepared remarks.
Since the first full human genome was sequenced in 2003 — providing a complete reading of the body’s instructions for making proteins, tissues and cells — there has been a revolution in understanding what drives tumor growth.
The Food and Drug Administration will soon announce a plan to update agency policies and facilitate the approval of critically needed drugs, including those known as tumor-agnostic therapies, which attack cancer-linked DNA, according to FDA Commissioner Scott Gottlieb.
Last month, the FDA approved the first tumor-agnostic drug, expanding the use of Merck’s blockbuster treatment Keytruda to patients with solid tumors that test positive for a certain mutated gene.
“We’ll clarify when we may be able to give a broad approval to a cancer drug, in multiple different kinds of molecularly similar cancers, that’s not particular to the tumor being in any one specific tissue or organ,” he said in his prepared remarks.
Since the first full human genome was sequenced in 2003 — providing a complete reading of the body’s instructions for making proteins, tissues and cells — there has been a revolution in understanding what drives tumor growth.