Women with mutations in the well-known BRCA1 or BRCA2 genes who have their breasts and ovaries removed are much more likely to survive than women who do not get preventive surgery, U.S. researchers said on Tuesday.

The study shows the benefits of genetic tests that give women with a family history of cancer the chance to take steps to increase their chances of survival, they said.

“This is the first study to prove women survive longer with these preventive surgeries and shows the importance of genetic testing when there is a family history of early breast or ovarian cancer,” Dr. Virginia Kaklamani of Northwestern University in Chicago wrote in a commentary about the study published in the Journal of the American Medical Association.

Women with mutations in the BRCA1 or BRCA2 genes have a 56 to 84 percent higher risk of developing breast cancer during their lifetimes.

Those with the BRCA1 mutation also have a 36 to 63 percent higher risk of ovarian cancer and those with the BRCA2 mutation have a 10 to 27 percent higher risk of ovarian cancer.

Because of this, many women make the difficult choice to have their breasts or ovaries and fallopian tubes surgically removed to reduce their risk.

Dr. Susan M. Domchek of the University of Pennsylvania School of Medicine in Philadelphia and colleagues studied the effectiveness of these procedures, comparing rates of cancer and death in 2,482 women who had the surgery with those who decided against it in favor of frequent cancer screenings.

No woman who had a mastectomy developed breast cancer during the three years of follow-up testing.

Seven percent of women who decided against a mastectomy were diagnosed with breast cancer in the same period.

“Our results confirm that risk-reducing mastectomy is associated with a significant reduction in breast cancer risk,” Domchek and colleagues wrote.

Women with BRCA1 and BRCA2 mutations who had their ovaries and fallopian tubes removed had similar results.

About 10 to 20 percent of breast and ovarian cancers are due to BRCA1 or BRCA2 genes. “Most of these women will die of ovarian cancer, so you can save 20 percent of them with the prophylactic surgery,” Kaklamani said.

“And you can save the majority of women who would have died of their breast cancer,” she added.

She said primary care physicians, gynecologists and women “need to be more aware that these tests exist.”

Dr. Sandhya Pruthi, a breast cancer expert at the Mayo Clinic in Rochester, Minnesota, who counsels women with BRCA mutations, said the study adds more evidence that the surgery can help save lives, but the choice is never easy.

“It’s not cookie-cutter medicine,” Pruthi, who was not involved in the study, said in a telephone interview.

She said women need to come to terms with the psychological issues involved in having their breasts removed, and younger women who have their ovaries removed must contend with early menopause symptoms.

“It’s not a decision made on a single visit,” she said.

According to the American Cancer Society and the International Agency for Research on Cancer, 1.3 million new breast cancer cases are diagnosed around the world every year and it kills 465,000 women annually, making it the leading global cancer killer of women.

Source: Reuters

Popularity: 1% [?]

New BLA is expected to be submitted in mid-2012.

FDA has sent Genentech a refuse to file (RTF) letter with regard to the BLA for accelerated approval of trastuzumab-DM1 (T-DM1) in metastatic breast cancer. The agency stated that the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of Her2 status, had not been exhausted in the study population.

Genentech will continue with its ongoing Phase III trial, known as EMILIA, and expects to submit a new BLA in mid-2012. The EMILIA study compares T-DM1 to lapatinib in combination with capecitabine in people with advanced, Her2-positive breast cancer whose disease has worsened after receiving initial treatment.

The BLA submitted for T-DM1 in July 2010 requested accelerated approval based on the results of a single-arm Phase II study. It showed that T-DM1 shrank tumors in one-third of women with advanced Her2-positive breast cancer who had received on average of seven prior medicines including two Her2-targeted medicines.

T-DM1 consists of ImmunoGen’s DM1 cancer-cell killing agent attached to Genentech’s Her2-targeting antibody, trastuzumab, using ImmunoGen’s linker and methods of attachment. T-DM1 is in global development by Roche under a collaboration agreement between Genentech and ImmunoGen.

Source: GEN

Popularity: 1% [?]

The National Institutes of Health named a committee on Monday to help guide research into the environmental and genetic causes of breast cancer.

The 19-member Interagency Breast Cancer and Environmental Research Coordinating Committee will meet in September to help decide where research money will be best spent.

“The broad range of expertise and insight of these individuals will ensure the federal research portfolio continues to advance our understanding of the critical links between our environment, our genes, and our health,” said Linda Birnbaum, director of the NIH’s National Institute of Environmental Health Sciences.

Members of the panel include experts at federal agencies, doctors and advocates.

Congress mandated the panel last year, said Gwen Collman of the NIEHS, who will help facilitate the committee’s work.

“It was Congress who decided there was a need for some oversight and strategic organization of breast cancer research,” Collman said in a telephone interview.

Scientists realized the importance of including advocacy groups when discussing research and where best to spend money, she said.

“I think this experience of having advocates speak to scientists and vice versa has begun a process where there is education on both ends on what’s important here.”

One in eight U.S. women will be diagnosed with breast cancer, the second-leading cause of cancer death among American women after lung cancer. It kills 500,000 people globally every year and is diagnosed in close to 1.3 million people.

The risk rises as a woman gets older and several genes are linked with breast cancer. Obesity, use of hormones, and childbearing also affect the risk but a significant percentage of cases cannot be explained yet.

Death rates from cancer are falling in the United States, but many people fear chemicals or other outside factors may cause a variety of cancers, and researchers are keen to ensure that scarce research dollars are spent in the best way.

Source: Reuters

Popularity: 2% [?]

An FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer has drawn rough words from a Republican senator. David Vitter of Louisiana called the decision “essentially government rationing.”

The advisory panel last week voted 12-1 to remove the breast cancer indication from the drug’s label. If the FDA follows the advice of its committee — as it often does — the drug could still be marketed to treat colon, lung and other cancers. New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.

“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.

“I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy,” he wrote.

Vitter’s mother-in-law died of breast cancer. He has slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn’t be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency’s website.

His Avastin statements, says an aide, were partly prompted by an online petition sponsored, according to the petition’s website, by “women with metastatic breast cancer.” The petition was created using a website called Care2, which offers “do-it-yourself tools for creating and promoting a petition” and says “it’s never been easier to support the causes you care about.” The petition overview says, in part, that “despite the study this drug is a miracle drug for some of (sic) metastatic breast cancer patients especially with a type of breast cancer called triple negative.”

The FDA’s spokeswoman said the agency “will respond to Sen. Vitter in a timely fashion.” A final decision on Avastin’s use in breast cancer is expected this fall.

Source: The Wall Street Journal

Popularity: 2% [?]

Roche shares hit 52-week low, and final decision is expected by mid-September.

Roche’s Genentech confirmed that FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12–1 in favor of retracting Avastin’s existing provisional endorsement as first-line therapy combined with paclitaxel against advanced Her2-negative breast cancer. FDA is expected to make a final decision on whether to rubber stamp the committee’s recommendation by September 17.

Genentech admits that it is “disappointed by the ODAC conclusion” and says that it will continue to discuss data from the three relevant Phase III Avastin studies. “We believe Avastin should be an option for women with this incurable disease,” stresses Sandra Horning, M.D., Genentech’s svp and global head of clinical development hematology/oncology. The firm also points out that whatever the outcome, the U.S. ruling will not impact Avastin’s sanctioned uses for other cancer types or affect any approvals in other countries.

News of the ODAC’s recommendation caused Roche’s shares to slide 4.2% on the previous day’s close, effectively hitting a 52-week low and hovering at about the CHF 135–137 mark as the day’s announcement took its toll.

Avastin’s use in the U.S. as first-line combination therapy for Her2-negative breast cancer was sanctioned in February 2008 under FDA’s accelerated approval program. The decision was based on data from the Phase III E2100 study demonstrating an improvement in progression-free survival (PFS), Genentech explains. In November last year the firm submitted two sBLAs to FDA based on the Phase III Avado and Ribbon 1 trials, as part of its push to convert the accelerated approval to full approval. The two studies evaluated Avastin in combination with either docetaxel chemotherapy or with a taxane, anthracycline-based or capecitabine chemotherapy in women with advanced, previously untreated Her2-negative breast cancer.

Avastin was first approved for the treatment of breast cancer by the EMEA in combination with paclitaxel for first-line therapy of advanced Her2-negative disease in 2007. In July 2009, the approval was expanded to include Avastin in combination with docetaxel.

Avastin is currently approved in major markets including the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small-cell lung cancer, and kidney cancer. The drug is also available in the U.S. for the treatment of patients with advanced brain cancer.

As Roche’s top-selling drug in 2009, Avastin made sales of CHF 6.2 billion (some $5.9 billion), up 21% on 2008 in local currencies, and representing 16% of overall sales.

Source: GEN

Popularity: 3% [?]

Vote to Revoke: Roche’s Avastin will lose its FDA seal of approval for treating breast cancer if the agency follows the advice of its oncology drugs advisory panel, the WSJ reports. The committee voted yesterday to remove the indication for breast cancer from Avastin’s label, though the drug would retain its approval for use in colon, lung and other cancers. The FDA usually, but not always, follows the advice of its advisory panels; a decision is expected by Sept. 17.

Drawing a Line: Harvard Medical School will institute stricter limits on the financial relationships between its faculty members and pharma, biotech and medical device companies, the Boston Globe reports. In addition to restricting gifts, meals and payments for speeches and consulting to its faculty, it will also separate the promotional activities of companies from the academic programs the school offers at continuing medical education events, the paper says.

Moving On: The president of WellPoint’s Anthem Blue Cross unit in California, which became a flashpoint for the debate over health insurance rate increases, is leaving the company, the WSJ reports. Leslie Margolin will now head up a coalition of providers, insurers and consumer advocates that will attempt to lower health-care costs through a “virtual” integrated system, the paper says.

A Place to Vent: If a business wants to air its concerns over the new health-care overhaul law, it now has an outlet — a website set up by the U.S. Chamber of Commerce, The Hill reports. The group criticized the legislation as being bad for business interests, but advocacy group Families USA says tax credits included in the bill will actually be a boon for small businesses, the paper says.

Source: The Wall Street Journal

Popularity: 3% [?]

The American Society of Clinical Oncology issued new guidelines on Monday for the use of hormone-based breast cancer drugs called aromatase inhibitors.

They said most breast cancer patients past menopause should consider taking an aromatase inhibitor at some point, either right after surgery or after two to three years of the drug tamoxifen.

“Women can take up to five years of an aromatase inhibitor therapy,” ASCO said in a statement to be published in the group’s Journal of Clinical Oncology.

Aromatase inhibitors include anastrozole, made by AstraZeneca under the brand name Arimidex, exemestane, made by Pfizer Inc, under the brand name Aromasin and Novartis’s Femara or letrozole.

Breast cancer is the second-leading cause of cancer death among U.S. women, after lung cancer. It kills 500,000 people globally every year and is diagnosed in close to 1.3 million people globally.

About 75 percent of these cancers are estrogen-receptor positive, meaning they are driven by hormones. Tamoxifen was the first drug to block the effects of estrogen and the aromatase inhibitors are the next generation.

Studies have shown that women who took tamoxifen for 5 years were 50 percent less likely to have their cancer return and the aromatase inhibitors have similar effects. But if a breast cancer patient has not gone through menopause, tamoxifen is the only safe hormone-based drug to take.

“One of the most important treatments for women with postmenopausal breast cancer is anti-estrogen therapy,” ASCO’s Dr. Harold Burstein, an oncologist at Harvard Medical School in Boston, said in a statement.

“Our panel carefully reviewed the explosion of research that has emerged in the past five years on anti-estrogen drugs, and filled in gaps in our understanding of how best to use these newer treatments, and what the trade-offs and side effects of therapy would be.”

Some studies suggest it is safe to take tamoxifen and an aromatase inhibitor — usually a pill taken daily — for as long as 10 years in total, the panel said.

“While the two drug classes work differently, overall, most women have relatively mild side effects on either drug,” ASCO added.

Source: Reuters

Popularity: 4% [?]

Roche’s blockbuster cancer drug Avastin has been spurned once again by Britain’s health cost watchdog NICE, this time as a treatment for breast cancer.

The National Institute for Health and Clinical Excellence (NICE) said on Friday it was rejecting the drug for patients whose breast cancer has spread to other parts of the body due to “uncertain evidence.”

Avastin, whose generic name is bevacizumab, is also licensed as a treatment for a number of other cancers — but it has not been approved by NICE for use in any of these.

It is widely used for treating bowel, lung, breast and kidney cancer in other countries and had worldwide sales of 6.2 billion Swiss francs ($5.90 billion) last year.

Draft guidance from the agency, which decides if drugs should be paid for by the country’s taxpayer-funded National Health Service (NHS), concluded that evidence on Avastin did not show it significantly improved or extended lives in breast cancer.

“The clinical trial results for bevacizumab were disappointing in that they were unable to prove definitively that the drug could extend the lives of patients with metastatic breast cancer over and above currently available treatments,” said NICE Chief Executive Andrew Dillon.

The NICE ruling comes ahead of a Food and Drug Administration advisory panel meeting on Avastin on July 20, when experts will consider whether or not to endorse full approval of the medicine in breast cancer in the United States.

Roche said its drug, when added to chemotherapy, had been shown to reduce the risk of a woman’s disease progressing by half and it would work with the British government to explore all possible ways of making Avastin available to patients.

A company spokeswoman said Roche had submitted a patient access scheme to NICE, which would place a cap on the amount the NHS would pay for the treatment of each woman. The plan has not yet been included in NICE’s evaluation as it is still pending approval from the Department of Health.

NICE also decided in separate draft guidance not to recommend Takeda’s bone cancer drug Mepact, or mifamurtide, because of uncertainties over its effectiveness and its high cost.

Source: Reuters

Popularity: 3% [?]

Wowed by stellar mid-stage data, Roche has filed a BLA for trastuzumab-DM1, or T-DM1, seeking approval to market the pioneering conjugated monoclonal antibody to women with treatment-resistant HER2 positive breast cancer. For Roche, T-DM1 represents a potential mega-blockbuster capable of eventually rivaling Herceptin in the market for cancer drugs. And the filing marks a major milestone for the investigators at Genentech and Immunogen who successfully combined a monoclonal antibody with a toxic chemotherapy to single out cancer cells for termination–sparing healthy cells.

“Conjugated monoclonal antibodies [such as T-DM1] are viewed by thought leaders in oncology as one of the next area[s] of significant innovation for the treatment of cancer,” Andrew Weiss of Bank Vontobel tells the Wall Street Journal.

If granted an accelerated review, Roche could gain marketing clearance in as little as six months to begin treating advanced breast cancer cases. In the meantime, Roche is pursuing an ambitious slate of late-stage trials to build T-DM1 into a major franchise drug. In Phase II, the drug shrank the tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer–making T-DM1 a last line of defense, according to a statement. That argument will help Roche make a compelling case for approval on the basis of mid-stage data.

“While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options,” says Hal Barron, Roche’s chief medical officer. “Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes offering a potential new medicine to people with this type of breast cancer.”

Source: FierceBiotech

Popularity: 3% [?]

Swiss drugmaker Roche Holding AG has submitted a new breast cancer drug for approval with U.S. health regulators, the group said on Wednesday, taking the innovative treatment a step closer toward the market.

Roche said it filed trastuzumab-DM1 (T-DM1) for approval with the U.S. Food and Drug Administration (FDA) for people with advanced HER2-positive breast cancer who had previously received other treatments.

A mid-stage phase II study showed that the drug shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer, Roche said.

Roche has said the new drug could eventually rake in sales of over 2 billion Swiss francs ($1.88 billion).

The news is also a boost for ImmunoGen as the drug comprises ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting antibody trastuzumab, or Herceptin, and would be the first product developed by ImmunoGen filed for approval.

Breast cancer is the second-leading cause of cancer death among women in the U.S. and approximately 15 to 30 percent of breast cancers are HER2-positive, Roche said.

When HER2-positive breast cancer is advanced, the disease has spread to other parts of the body, most commonly to the lungs, bones, liver and brain.

Roche had already said it aimed to file T-DMI1 for approval after phase II, adding the drug’s launch could take place in the beginning of 2011, if approved.

Roche will still conduct Phase III studies. Drugmakers usually file for approval after final trial outcomes.

The success of new drugs is key for the world’s largest maker of cancer drugs, as competitors work on rival products to some of Roche’s best-selling medicines.

In addition, Roche’s blockbusters MabThera and Herceptin could become vulnerable to so-called biosimilar drugs as they lose their patent protection in a several European countries in 2014 and 2015.

Source: Reuters

Popularity: 2% [?]