The AP 
(1/18) reports, "The Food and Drug Administration says it approved a
drug to reduce dangerous levels of a certain chemotherapy drug in cancer
patients with failing kidneys." The new medicine, produced by "BTG
International Inc. breaks up a chemotherapy drug called methotrexate so
that it can be eliminated from the body." According to study results
used to support the agency's approval, "patients taking the drug,
Voraxaze [glucarpidase], eliminated 95 percent of the methotrexate in
their system." Common side effects included low
blood pressure, headaches, nausea and vomiting.
(1/18) reports, "The Food and Drug Administration says it approved a
drug to reduce dangerous levels of a certain chemotherapy drug in cancer
patients with failing kidneys." The new medicine, produced by "BTG
International Inc. breaks up a chemotherapy drug called methotrexate so
that it can be eliminated from the body." According to study results
used to support the agency's approval, "patients taking the drug,
Voraxaze [glucarpidase], eliminated 95 percent of the methotrexate in
their system." Common side effects included low
blood pressure, headaches, nausea and vomiting.
Bloomberg News
(1/18, Edney) quotes Richard Pazdur, director of the FDA's Office of
Hematology and Oncology Products, who said, "Voraxaze is an important
new treatment option for cancer patients aimed at preventing these
toxicities associated with sustained high levels of methotrexate."
According to the National Institutes of Health, "Methotrexate can cause
death, liver and lung damage and may leave patients susceptible to
serious infections." The company "withdrew its European application for
Voraxaze in 2007 after the European
Medicines Agency raised concerns that the purity of the product may have
been affected by a plan to manufacture the drug at a factory that
hadn't been used to make the medicine for clinical trials." Also
covering the story is Reuters (1/18, Yukhananov) and the Boston Globe (1/18).
(1/18, Edney) quotes Richard Pazdur, director of the FDA's Office of
Hematology and Oncology Products, who said, "Voraxaze is an important
new treatment option for cancer patients aimed at preventing these
toxicities associated with sustained high levels of methotrexate."
According to the National Institutes of Health, "Methotrexate can cause
death, liver and lung damage and may leave patients susceptible to
serious infections." The company "withdrew its European application for
Voraxaze in 2007 after the European
Medicines Agency raised concerns that the purity of the product may have
been affected by a plan to manufacture the drug at a factory that
hadn't been used to make the medicine for clinical trials." Also
covering the story is Reuters (1/18, Yukhananov) and the Boston Globe (1/18).
No comments:
Post a Comment