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Glaxo’s Tyverb Referred for More Discussion in Europe

March 19, 2008

By Andrea Gerlin and Angela Cullen, Bloomberg News

GlaxoSmithKline Plc’s Tyverb breast cancer drug was sent back to a European regulatory panel after new data showed the medicine may raise the risk of liver damage, slowing final approval.

The European Medicines Agency said in December that it recommended conditional approval of Tyverb for breast cancer that has advanced or spread to other parts of the body in patients with the HER-2 gene, which makes the disease more aggressive. Conditional approval is valid for one year while the company obtains more information about the medicine and its effectiveness, EMEA said at the time.

High BMI means bad news for breast cancer patients

March 15, 2008

By The Hindu

Women with locally advanced breast cancer or an inflammatory form of the disease have worse prognosis if they are obese or have a high Body Mass Index (BMI), the measure of a person’s fat based on their height and weight.

According to a new study, BMI may be an effective prognostic tool for specific types of breast cancer.

The High Cost of a Cancer Drug

March 11, 2008

By New York Times Editorial

The Food and Drug Administration’s recent approval of Avastin, a hugely expensive drug, to treat advanced breast cancer has raised perplexing issues for women, their doctors and the entire health care system.

The drug had previously been approved to treat colorectal and lung cancers, extending the lives of patients by a few months. Now the F.D.A. has granted Avastin “accelerated approval” for use in metastatic breast cancer on the basis of a clinical trial that showed it slowed progression of the disease but did not significantly extend the lives of patients.

The key study showed that when used with another drug, Avastin almost doubled the time cancers were held in check before starting to worsen. It also doubled the number of women whose tumors shrank significantly.

It did not extend overall survival rates and caused more serious side effects, including perhaps half a dozen deaths. That seems like a modest basis for approval pending completion of additional clinical trials. The quandary is whether an extra 5 1/2 months of holding tumor progression at bay is worth toxic side effects.

The drug is already prescribed “off label” for some 11,000 American women with advanced breast cancer, but the latest approval is expected to increase its use among some 43,000 women deemed suitable candidates for treatment. The cost could be enormous. Genentech charges about $92,000 a year for breast cancer patients. For women with annual family incomes below about $100,000, it caps the charges at $55,000 a year.

The company argues that Avastin emerged from many years of costly research. It does not claim that the drug is cost-effective for advanced breast cancer but believes it will clearly be worth the cost if shown effective in earlier stages of breast cancer.

Britain’s National Health Service has balked at paying for Avastin for breast cancer patients. If this country hopes to get escalating health care costs under control, it will need a way to determine which treatments are worth paying for, and which are not. The case of Avastin is a reminder of just how difficult that can be.

Stem Cell Protein Stops Cancer in its Tracks

March 6, 2008

By Ivanhoe Newswire

A protein found in human embryonic stem cells is showing promise in fending off the spread of deadly cancers.

Northwestern researchers say the protein, which they’ve dubbed “Lefty,” inhibits the production of another protein known as Nodal, found in embryonic stem cells and cancer cells alike. Under normal circumstances, Nodal plays a key role in helping embryonic stem cells turn into the different cells needed in the human body, such as tissue cells, skin cells, etc.

Cancer drug: How good is good enough?

March 4, 2008

By Stephen Smith, Boston Globe

Does slowing the fire justify use of a medication?  

In patients stricken with advanced breast cancer, the disease can rage like a wildfire, jumping from hot spot to hot spot, sparking pain and disability.   

So if there’s a drug that can slow the fire for a while, even if it’s not ultimately doused, does that justify use of the medication? And at what cost, to the patient and to society?  

Late last month, federal drug regulators gave their answer when they approved a drug called Avastin for treatment of patients with advanced breast cancer. The decision proved controversial because research showed that the patients on the drug didn’t live significantly longer, even though they had more time without tumor growth than patients not on Avastin. 

Study Finds Death Risk From Anemia Drugs

February 28, 2008

Widely used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death among cancer patients by about 10 percent, according to a new analysis of previous clinical trials that is to be published Wednesday.

The study is the first compilation of clinical trial data — called a meta-analysis — to show a statistically significant increase in the risk of death from the drugs, said Dr. Charles L. Bennett, a professor at Northwestern University and its lead author. 

New Anti-cancer Agent Can Overcome Drug Resistance, Says Study

February 26, 2008

By Science Daily

 A new anti-cancer agent that targets breast cancer can overcome resistance to cancer drugs, according to a new study by the Imperial College London.

Many tumours that are initially responsive to chemotherapy can develop resistance to it, allowing the cancer to progress. Studies have shown that one of the key reasons for the development of resistance is a protein pump called P-glycoprotein. Resistant cancer cells express P-glycoprotein and this removes anti-cancer drugs from the cell before they are able to kill the cell.

The new study shows that P-glycoprotein is not able to remove a recently identified anti-cancer agent known as STX140 from cancer cells. STX140 works by stimulating a natural cell suicide process and is able to kill cancer cells which express the P-glycoprotein pump.

Avastin OK’d for breast cancer

February 23, 2008

By Daniel Costello, LA Times

FDA approves the drug’s use despite a lack of evidence that it extends patients’ lives.

In a surprise decision that could portend significant changes in how federal regulators approve cancer drugs, the Food and Drug Administration Friday approved the use of a $100,000-a-year drug for use by women with breast cancer although there is little evidence it helps breast cancer patients live longer.

Avastin, manufactured by South San Francisco-based biotech giant Genentech Inc., is already a blockbuster cancer drug used to treat advanced colon and lung cancer. Research shows the drug slows the progress of breast cancer tumors by more than five months but does not extend patients’ lives.

FDA Nears Ruling on Avastin for Breast Cancer

February 21, 2008

By Wall Street Journal

FDA is close to ruling on Avastin for Breast Cancer.

Genentech Inc.’s push to market Avastin for breast cancer has split the cancer community, which remains divided despite an 11th-hour boost last week from news of a study involving the drug by Genentech’s majority shareholder, Roche Holding AG.

The FDA is due to decide on Avastin by Saturday, but the outcome is far from assured. Members of an agency advisory committee voted 5-4 against approval in December. While the FDA isn’t required to follow the panel’s recommendations, it usually does. European regulatory authorities approved Avastin for breast cancer last March.

New Phase 2b Clinical Trial for MBC Patients treated with Avastin(R)

February 16, 2008

By MedicalNewsToday.com

Accelerated Community Oncology Research Network, Inc. (ACORN), announced the initiation of a Phase 2b clinical trial evaluating the efficacy of Nexavar(R) (sorafenib) tablets in combination with the anticancer drug gemcitabine (Gemzar(R)) in patients with metastatic breast cancer whose cancer has progressed during or after treatment with bevacizumab (Avastin(R)).

The double-blind, randomized trial will enroll a total of 220 patients at approximately 45 sites in approximately 20 states and will assess efficacy, safety and patient quality of life as endpoints. Patients will be randomly assigned to receive either Nexavar and gemcitabine, or placebo and gemcitabine.

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