The drug, Keytruda, was given breakthrough therapy
designation and a sped-up approval because it was deemed to be a
significant improvement over available treatments based on the results
of clinical trials.
"Our growing understanding of underlying molecular pathways
and how our immune system interacts with cancer is leading to important
advances in medicine," Dr. Richard Pazdur, director of the Office of
Hematology and Oncology Products in the FDA's Center for Drug Evaluation
and Research.
Keytruda blocks a cellular pathway found in the body's immune cells
and some cancer cells, helping the immune system fight cancer cells. The
drug specifically works in patients with a genetic mutation, which the
FDA requires patients be tested for in order to be eligible for the
treatment.
The drug was tested with 550 advanced lung cancer patients, 61 of
whom had the genetic mutation and already been treated with
chemotherapy. In 41 percent of patients, tumors shrank after treatment
with the drug, an effect that lasted between 2.1 and 9.1 months.
"The approval of this drug and a test to identify patients most
likely to benefit has the potential to transform the way that lung
cancer is treated."
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