PHARMACY

Avastin study on pancreatic cancer effects mixed results

BY Allison Cerra

ZURICH , Switzerland A new late-stage study of Roche Holding’s Avastin, and its effectiveness to slow down or avert pancreatic cancer in patients, had mixed results, the company said Tuesday.

The Swiss drugmaker said that although the addition of its drug to a Tarceva-chemotherapy combination failed to prolong the lives of patients with advanced pancreatic cancer, certain subjects did have some benefits when using Avastin.

Roche said that the study, which included 607 patients, showed that adding Avastin prolonged the time patients lived without their cancer worsening, as well as adding safety benefits.

An earlier trial, the company said, utilizing the same experiment, concluded that the addition of Avastin had shown no benefit in the treatment of pancreatic cancer.

Roche, which sponsored the study known as AVITA, plans to further analyze the data to determine the extent of the benefit of adding Avastin to the Tarceva-chemotherapy combination. The new details that surfaced from the study will not be published, the drugmaker said.

Pancreatic cancer, deemed the most difficult form of cancer to treat, is frequently resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body. It leads to the shortest life expectancy of any major tumor.

Avastin, which hinders the growth of tumors by restraining their blood supply, was jointly developed with Genentech, a U.S. biotechnology company (majority-owned by Roche), and is seen as one of Roche’s most important drugs.

Financial experts believe Avastin will eventually become Roche’s best-selling drug, according to Dow Jones, since the drug is expected to be approved to treat several types of cancers.

Avastin was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer, and was approved for the treatment of lung cancer one year later. It is currently awaiting sanction for use in breast cancer. In Europe, it won approval for the treatment of advanced breast cancer and lung cancer earlier this year.

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Cephalon submits application to FDA for supplemental uses of Fentora

BY Drew Buono

FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.

Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.

In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.

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Reverse-payment bill held up in Congress by pharmaceutical lobbying

BY Drew Buono

WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.

The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.

An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.

More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.

And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.

“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”

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