U.S. health regulators on Wednesday
swiftly approved a Bristol-Myers Squibb Co drug that
helps the immune system fight the most common form of lung
cancer. The eagerly anticipated Food and Drug Administration
approval of the drug known as Opdivo came only about three
months after Bristol provided trial results showing that the
medicine extended survival in non-small cell lung cancer
(NSCLC), one of the biggest markets in oncology. The decision
also came more than three months ahead of an expected action
date by the agency.
"This approval will provide patients and health care
providers knowledge of the survival advantage associated with
Opdivo and will help guide patient care and future lung cancer
trials," Richard Pazdur, the FDA's head of hematology and
oncology product evaluation, said in a statement.
Opdivo, known chemically as nivolumab, was approved to
treat non-small cell lung cancer after the disease has
progressed following platinum-based chemotherapy, typically the
first-line treatment against the disease. It was previously
approved to treat advanced melanoma, the deadliest form of skin
cancer.
Opdivo belongs to a highly promising new class of medicines
called PD-1 inhibitors that work by blocking a mechanism tumors
use to hide from the immune system, allowing it to recognize and
attack cancer cells.
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