Perjeta (pertuzumab) was approved by the Food and Drug Administration for the treatment of people with terminal cancer HER2-positive, the agency said in a news release.
HER2 is a protein involved in cell growth. Increasing the amount of protein, which can promote the growth and survival of cancer cells, found in approximately 20 percent of cases of breast cancer, said FDA.
Perjeta approved for people who have not been treated with anti-HER2 therapy for metastatic breast cancer (spread), the agency said.
However, the FDA warns that ?unspecified? production problems faced by producers of Genentech ?can affect the long term supply of drugs.? The agency said the drug makers? who are committed to taking measures to solve production problems on the right. ?
The safety and efficacy of drugs were evaluated in clinical studies of 808 people with HER2-positive. The most common side effects noted were diarrhea, hair loss, decrease in white blood cells, nausea, fatigue, rash and nerve damage.
The drug was approved with a warning on the label ?black box? of potential loss from death or serious side effects in infants. Pregnancy status of women must be verified before starting treatment with the drug, the FDA said.
San Francisco, Genentech is a unit of the Roche Group.
Source: http://amnesia.us/2012/07/perjeta-approved-for-advanced-breast-cancer.html
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