The Food and Drug Adminstration and Genentech have reported that counterfeit Avastin is being distributed in the United States. The counterfeit medicine does not contain
bevacizumab, Avastin’s active ingredient.

The packaging is different from genuine Avastin marketed here by Genentech. It includes a Roche logo which isn’t on the real drug, along with different codes.

Avastin is not in shortage now, and there are adequate supplies to meet the need.

Patients being treated with Avastin are urged to let their doctors know immediately if they have unusual symptoms. Read the rest of this entry »

When Avastin is added to the combination of Xeloda and irinotecan as an initial treatment for advanced colorectal cancer, the treatment is equally effective as Avastin with FOLFIRI.

But side effects are more difficult.

After a randomized clinical trial comparing Avastin with XELIRI (Xeloda, irinotecan) to Avastin with FOLFIRI (5-FU, leucovorin, irinotecan), researchers concluded that excessive side effects made using the XELIRI combination unwise. Read the rest of this entry »

Although FDA Commissioner Margaret Hamburg announced a final decision on November 18 to drop breast cancer from the Avastin label, metastatic colorectal cancer continues to be an approved use.

The Avastin® (bevacizumab) label includes the following approved indication:

Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment.

It is important to know that there is currently no approval or evidence for using Avastin alone or in early stage colon or rectal cancer.

The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including

• Loss of ovarian function (ovarian failure).
• Bone death in the jaw (osteonecrosis).
• Bleeding and additional blood clots in patients who have already had a clot in their veins while on Avastin.

Changes to the Avastin label were announced on September 30, 2011. Read the rest of this entry »

Yesterday’s recommendation by the FDA’s Oncology Drug Advisory Committee (ODAC) that approval of Avastin for breast cancer be withdrawn will not affect colorectal cancer treatment.

Avastin® (bevacizumab) remains on the market in the US and is FDA-approved  for advanced colon and rectal cancer in combination with chemotherapy, both as first-line and second-line therapy.

The public hearing held on June 28 and 29 reviewed the process began  in December, 2010 to withdraw the FDA provisional approval of Avastin for metastatic, HER-2 negative breast cancer.  It did not consider or change other label indications for colorectal, kidney, or small cell lung cancers or glioblastoma.

A final decision on breast cancer will be made by the FDA Commissioner Margaret Hamburg, MD.  Until then the indication for breast cancer will remain on the FDA-approved label. Read the rest of this entry »