The U.S. Food
and Drug Administration said on Thursday it has approved Amgen Inc's cancer
drug Kyprolis in combination with certain other therapies to treat patients
with multiple myeloma.
"Kyprolis
is the only approved therapy for relapsed multiple myeloma with proven efficacy
as a single agent, doublet and triplet combination that is offered in a
variety of doses to meet individual patient needs," said Sean E.
Harper, M.D., executive vice president of Research and Development
at Amgen. "Importantly, this new approval supports the use of
Kyprolis as a backbone therapy for the management of relapsed multiple myeloma,
a difficult-to-treat blood cancer."
KYPROLIS:
The drug will
be used in combination with dexamethasone or lenalidomide, plus dexamethasone,
for relapsed or refractory multiple myeloma (MM) patients, who have received
one to two therapies.
Kyprolis is
also approved as a single agent, for the same condition. The drug's mode
of action is to prevent the breakdown of proteins in cancer cells, thereby
killing them. The disease is incurable, but effective drugs can help manage the
symptom profile.
MM is a fatal
blood cancer that develops in the plasma cells, and matures in the bone marrow,
a place where normal cells are formed. In a MM patient, abnormal plasma cells
interfere with the growth and development of normal blood cells and kills.
Amgen said the
agency approved Kyprolis in combination with dexamethasone or with the drug
lenalidomide plus dexamethasone for relapsed or refractory patients. It
approved the drug as a single agent for patients with relapsed or refractory
disease who have received one or more treatments.
No comments:
Post a Comment