PHARMACY

FDA to review Genentech’s applicaiton of Avastin as breast cancer drug

BY Adam Kraemer

WASHINGTON The Food and Drug Administration has determined that Avastin (bevacizumab), a Genentech drug indicated for the treatment of colorectal cancer, did not significantly help women with breast cancer live longer, the New York Times has reported.

Coming close on the heels of a pricing inquiry by Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, the news seems to herald another headache for Genenentech.

An advisory committee to the FDA will meet Wednesday to discuss whether Avastin will win an additional approval for breast cancer. The drug had $1.7 billion in United States sales in the first nine months of the year.

The question, according to the FDA, is whether the benefits outweigh the costs. While the study showed that the overall survival rate for breast cancer patients did not significantly change with Avastin, the length of time before symptoms worsened nearly doubled when the drug was taken in combination with paclitaxel. However, the FDA is often more likely to look at overall survival, rather than what is known as progression-free survival.

In addition, as with many cancer drugs, Avastin can have serious side effects. The FDA said that 71 percent of the women who got Avastin suffered from a serious side effect, compared with 51 percent of the women who got paclitaxel alone. Among these were the deaths of at least five patients that the FDA said were probably or definitely due to the treatment itself, representing 1.4 percent of the women getting Avastin. There were no deaths from the treatment itself among women getting only paclitaxel.

FDA staff did not take a position on whether Avastin should be approved for breast cancer.

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Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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