FDA approves BTG's drug for cancer toxicity

FDA approves BTG's drug for cancer toxicity











(Reuters) - U.S. health regulators gave the nod on Tuesday to a drug
from British specialty drugmaker BTG Plc that helps cancer patients get
rid of toxic levels of a chemotherapy treatment.

The drug, called Voraxaze, helps
eliminate methotrexate in patients whose kidney function has been
compromised by treatment with high doses of the chemotherapy agent.
Methotrexate is normally eliminated from the body by the kidneys, but
prolonged high doses of the drug used to treat cancer can result in
kidney failure.

BTG's injectable treatment can quickly break down the chemotherapy medicine and allow the body to expel it.
The Food and Drug Administration granted
Voraxaze orphan drug status, meant for rare diseases or conditions
that affect a very small portion of the population. As incentive for
companies to develop such drugs, the orphan designation comes with
seven years of marketing exclusivity before a rival medicine could be
approved.

Methotrexate is used to treat breast,
bone and lung cancer as well as leukemia. In much lower doses, it is
commonly used to treat rheumatoid arthritis and other autoimmune
diseases.

Prolonged exposure to the chemotherapy
treatment can cause kidney and liver damage, skin rash and severe mouth
sores, damage to the lining of the intestines, and death because of
low blood counts, said Richard Pazdur, the head of the FDA's cancer
drugs division.

"Voraxaze is an important new treatment
option for cancer patients aimed at preventing these toxicities
associated with sustained high levels of methotrexate," Pazdur said in a
statement.

In a clinical trial of 22 patients,
Voraxaze eliminated 95 percent of methotrexate from their blood. For 10
of the patients, the methotrexate fell to a low level within 15
minutes and stayed that way for eight days, the FDA said.
Common side effects included low blood pressure, headaches, nausea and vomiting.


Source:-

http://www.reuters.com/article/2012/01/17/us-fda-voraxaze-idUSTRE80G2FE20120117