The New York Times
(7/21, B4, Pollack, Subscription Publication) reports that the Food
and Drug Administration granted approval to a "multiple myeloma drug,
Kyprolis [carfilzomib] from Onyx Pharmaceuticals, [which] was approved
for use when at least two other drugs have failed." Carfilzomib
"received accelerated approval," after a study in which "the drug
significantly shrank tumors in 23 percent of patients who had relapsed
after receiving at least two previous therapies."
The Wall Street Journal
(7/21, Winslow, Chaudhuri, Subscription Publication) reports that
multiple myeloma is expected to be diagnosed in 21,700 new US patients
this year. It explains that the FDA approved it after a study of 266
patients.
The AP
(7/20) reports, "The injectable drug Kyprolis treats multiple myeloma,
a form of cancer that causes tumors to grow in the bone marrow,
preventing the production of normal blood cells." The study covered
"266 patients with advanced multiple myeloma who had already been
treated with Velcade and thalidomide." Also, "thirty percent of
patients experienced side effects from the drug, including fatigue,
fever, shortness of
breath and diarrhea." The San Francisco Business Times (7/20, Subscription Publication) in its "Biotech SF" blog also reported the approval.
Reuters (7/20, Yukhananov) reports that the company said up to 15,000 patients in the US may be eligible for the medication.
MedPage Today
(7/23, Bankhead) reports, "The approval covers patients who have
relapsed or refractory myeloma that has not responded to at least two
prior regimens, one of which must be bortezomib (Velcade)." Richard
Pazdur, MD, director of the FDA Office of Hematology and Oncology
Products, said in a statement, "The approval of Kyprolis provides a
treatment option to patients with multiple myeloma whose disease has
progressed
despite use of available therapies." Yet, "an FDA staff
report...expressed concern that carfilzomib's adverse events...might
negate any possible benefit."
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