New drug approved by FDA/copied article

roxanne53

Hello~
The copied article below about the approval of drug for mets breast cancer. Something to bring up to our oncologists regarding this new approach for treatment. Hope it is helpful.See below,
Roxanne

United Press International

Monday, January 10, 2005


WASHINGTON, Jan 08, 2005 (United Press International via COMTEX) -- The Food and Drug Administration has approved an injectable breast cancer treatment made by two U.S. pharmaceutical companies.

Abraxane, made by American Pharmaceutical Partners and American Bioscience is "indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy," a spokesman for the companies said.

Prior therapy should have included an anthracycline, "unless clinically contraindicated."

The FDA's approval marks a new class of "protein-bound particle" drugs for breast cancer patients, the companies said.

Abraxan is made of albumin-bound paclitaxel nanoparticles and is free of toxic solvents.

It has demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with the solvent-based Taxol in a prospectively randomized trial of 460 patients with metastatic breast cancer, the companies said.

roxanne53

For accuracy sake::
Somehow this new topic got in wrong date. I read and copied today, 1/11/05, to this site.
Roxanne

SusanAnne

Hi Roxanne,

I had just found this article yesterday. It's very interesting and will certainly be a topic of conversation at my next oncology visit.

FDA Approves New Breast Cancer Drugs
Tuesday, January 11, 2005
By Jennifer Warner

The FDA has approved the first in a new class of drugs that reduces the side effects and boosts the effectiveness of traditional breast cancer chemotherapy.

The drug, Abraxane, is part of a class of drugs known as “protein-bound particle” drugs, which represent a new way of delivering chemotherapy drugs to cancer patients.

By binding the active ingredient (the breast cancer drug Taxol) to microscopic protein molecules, these drugs eliminate the need for using toxic solvents to deliver the drugs into the bloodstream, and reduce potentially harmful side effects.

Because they contain no toxic solvents, researchers say protein-bound drugs enable doctors to use up to 50 percent higher doses of chemotherapy without compromising patient safety. This form of drugs also requires no premedication to prevent hypersensitivity reactions and can be given over a 30-minute period using standard intravenous tubing.

The FDA has approved the first of these drugs, Abraxane, for the treatment of breast cancer after failure of combination chemotherapy for disease that has spread beyond the breast, or breast cancer relapses within six months of chemotherapy treatment.

Clinical trials of Abraxane showed that it produced nearly double the response rate compared with solvent-based Taxol chemotherapy in a group of 460 women with advanced breast cancer.