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% [?]

U.S. cancer death rates are falling, with big decreases in major killers such as colon and lung cancer, the American Cancer Society said on Wednesday.

The improvement was due a decline in smoking, better treatment and earlier detection, it said.

The group predicted 1,529,560 new cancer cases in the United States in 2010 and 569,490 deaths.

Death rates for all cancer types fell by 2 percent a year from 2001 to 2006 among men and 1.5 percent per year from 2002 to 2006 in women, it said.

New cases of colorectal cancer fell 3 percent a year in men and 2.2 percent a year for women from 1998 to 2006, while lung cancer rates have fallen in men by 1.8 percent each year since 1991 and finally started leveling off among women.

“We will build on our progress in the fight against cancer through laws and policies that increase access to cancer prevention, early detection, and treatment services, and with a sustained federal investment in research designed to find breakthroughs in the prevention and treatment of the most deadly forms of cancer,” John Seffrin, chief executive officer of the American Cancer Society, said in a statement.

FALLING MORTALITY RATE

The drops in mortality rates have meant 767,000 people who would have died prematurely from cancer over the past 20 years did not, the organization said.

The overall U.S. death rate from cancer in 2007 was 178.4 per 100,000 people, a 1.3 percent drop from 2006, when the rate was 180.7 per 100,000.

“In that time, mortality rates have decreased by 21 percent among men and by 12 percent among women, due primarily to declines in smoking, better treatments, and earlier detection of cancer,” the group said in a statement.

Lung cancer remains the No. 1 cancer killer of both men and women in the United States. Breast cancer comes in No. 2 for women, prostate cancer is the second most common killer of men, and colon cancer is the third leading cause of cancer death for both sexes.

On Tuesday, the U.S. Centers for Disease Control and Prevention said at least 10,000 people and possibly far more die in the United States each year because they have not been screened for colon or breast cancer.

The cancer society projects that 222,520 Americans will get lung cancer in 2010 and 157,300 will die. It says 102,900 will get colon cancer and 51,370 will die from it; 209,060 will get breast cancer and 40,230 will die; and 217,730 will get prostate cancer and 32,050 will die from it.

Source: Reuters

Popularity: 3% [?]

Cambridge, MA-based Curis has been handed a significant setback on its lead cancer program. The developer announced this morning that GDC-0449 flunked the primary endpoint in a Phase II colorectal cancer trial mounted by its partner Genentech, failing to outperform a combination of Avastin and chemotherapy. The news quickly lopped 46 percent off the value of its shares.

Researchers behind the 199-patient trial were looking to see whether the drug, in combination with Avastin and chemo, could beat the standard therapy in delaying disease progression or death. The company released only top-line results, with the hard data being reserved for an upcoming science confab.

Genentech mapped out an ambitious series of trials for the drug, and Curis execs–no doubt bracing for a painful hit on the stock price this morning–wasted no time in trying to shift attention to two other mid-stage trials for the therapy.

“Despite these disappointing results in metastatic colorectal cancer, we remain encouraged that Genentech and Roche’s clinical development of GDC-0449 in other cancers continues to make good progress,” said Dan Passeri, Curis’ president and CEO. “We continue to believe that GDC-0449 may offer potential benefit in other cancer indications because the Hedgehog pathway is thought to act via different mechanisms of action in other tumor types.”

Source: FierceBiotech

Popularity: 2% [?]

Hong Kong scientists say they have identified the cancer stem cells responsible for the spread of colorectal cancer to other organs and believe the find will revolutionize treatment.

Current treatments regard all cancer cells as alike, but the Hong Kong University researchers discovered that cancers contain a small number of stem cells responsible for starting and maintaining tumors.

“It will revolutionise the approach to cancer treatment in future,” one researcher, Ronnie Poon, told the South China Morning Post.

“If you just target mature cancer cells, you are not targeting the roots of the disease. What the industry needs to work on now is drugs that will target cancer stem cells,” the professor of surgery said.

The spread of colorectal cancer to other organs is usually fatal. The cancer is one of the most common in both men and women and kills around 50,000 people a year in the United States, according to the National Cancer Institute.

The ground-breaking research will help doctors to predict patients whose cancers are liable to spread and help development of treatments to specifically target the cancer stem cells, called CD26+, which are more resistant to conventional treatments than more mature cancer cells.

“Identification and characterisation of this subpopulation of cancer stem cells will enable us to evaluate for different molecular targeting drugs that can specifically target these cells,” researcher Roberta Pang said in a press release on their findings.

“In the long term, it should facilitate the development of more useful, safe and specific drugs that can be used in combination with chemotherapy to completely eradicate the tumour.”

Colorectal cancer is the second-most common cause of cancer-related death worldwide. Even with surgical removal of the primary tumour, cancer develops in other organs in more than 50 percent of patients, usually proving fatal despite further aggressive treatment and surgery.

Source: the raw story

Popularity: 2% [?]

A brief one-off screening test could prevent thousands of people dying from bowel cancer every year, a study published in the Lancet suggests.

There are now calls for the test to be rolled out across the UK after results from 200,000 people aged 55-64 found it cut deaths by 43% over 10 years.

Cancer Research UK described the results from the Imperial College, London, study as a “rare breakthrough”.

Independent advisers will consider the test, the Department of Health says.

The independent bowel cancer screening committee will discuss whether it would be cost-effective to incorporate the procedure – known as sigmoidoscopy – into the UK’s screening programmes.

Scientists from Imperial College, London, who carried out the research, argue the costs would be outweighed by the savings generated through reducing the incidence of the disease, the UK’s second biggest cancer killer.

Simple test

The current screening method for bowel cancer looks for traces of blood in the stools, one of the key symptoms of colorectal cancer. If this is found, the patient is referred for further investigation.

This test – using a flexible scope little wider than a pen to find and remove polyps, the precursors to cancer – is believed to reduce the death rates from the disease by 25% for those who use it.

But by finding and removing polyps – the mainly symptomless growths which can become cancerous – a sigmoidoscopy could stop the disease developing in the first place in the lower bowel.

Two thirds of colorectal cancers occur here.

Easier to conduct than a colonoscopy, which is not suitable for the general population because it requires sedation and can be a lengthy process because the entire bowel must be examined, a sigmoidoscopy can be carried out by a nurse and does not require any pain relief. Laxatives are taking in advance to clear the bowel.

A one-off examination of over 40,000 men and women aged between 55 and 64 in which any polyps were detected and removed reduced the number of cases of the disease by one third, and deaths by 43%, when compared with a group who received no intervention.

They were followed for an average of 11 years, and lead researcher Professor Wendy Atkin said the results showed people would only need one test in a lifetime.

Combined with the existing blood test to detect any cancers developing further up the colon, “thousands of lives could be saved”, she said.

Some 16,000 people die from bowel cancer every year. If the results of this study were extrapolated, about 3,000 would be saved.

Researchers calculate that one life would be saved for every 400 people screened, which compares favourably with breast cancer screening – where the figures are 500 mammograms for every life saved. The main cost would be recruiting the specialist nurses needed to carry out the examination.

“We don’t often use the word breakthrough, but there is a tremendous opportunity to use this procedure to push bowel cancer back down the league table of cancer cases in the UK,” said Harpal Kumar, head of Cancer Research UK, which helped fund the research.

“Cancer Research UK is calling on the next government to add the test to the existing national bowel screening programme as one of its first priorities.

“Such a programme, backed by all UK governments, would save thousands of lives, whilst also saving the NHS money.”

Bowel Cancer UK has also called for the test to be added to the existing screening programme.

And Professor Jon Rhodes, of the British Society of Gastroenterology, described the results as “very exciting”.

The British Society of Gastroenterology would welcome the establishment of early pilot centres to establish further data on service delivery and uptake in routine NHS practice,” he said.

Source: BBC NEWS

Popularity: 3% [?]

Pfizer is discontinuing its Phase III open-label trial of Sutent® in patients with advanced hepatocellular carcinoma. The decision comes as a result of an independent Data Monitoring Committee review of data from the SUN 1170 trial. This suggested that compared with treatment using Bayer HealthCare’s Nexavar, Sutent led to a higher incidence of serious adverse events and had no obvious benefits in terms of patient survival.

In March 2009, the study evaluating single-agent Sutent versus Roche’s Xeloda was halted. In June a second Phase III trial comparing first-line treatment of advanced breast cancer using either Sutent plus Taxol or Roche’s Avastin plus Taxol was also stopped due to lack of efficacy. Two separate Phase III trials in advanced breast cancer have been allowed to continue. In June 2009, Pfizer discontinued a Phase III trial of Sutent for first-line treatment of metastatic colorectal cancer, again due to futility.

Sutent is already approved for treating both advanced/metastatic renal cell carcinoma (mRCC) and gastrointestinal stromal tumors (GIST) in patients whose disease progressed after treatment with Novartis’ Gleevec, or who are intolerant to Gleevec. In December 2009, submissions were filed with U.S., European, and Japanese regulatory authorites for approval of Sutent in the treatment of pancreatic neuroendocrine cancer.

Pfizer is also carrying out Phase III trials with the drug as a treatment for advanced non-small-cell lung cancer, advanced castration-resistant prostate cancer, and advanced breast cancer as well as adjuvant therapy for renal cell carcinoma.

Pfizer says that the latest failure of the liver cancer trial hasn’t dented its confidence in the potential for Sutent. Mace Rothenberg, M.D., svp of clinical development and medical affairs at Pfizer’s oncology business unit, remarked, “the disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease. We are committed to patient safety and are working with investigators to better understand these trial results and their implications for clinical practice.”

The firm claims that as of the end of December 2009, Sutent was the best-selling medicine in the world for the treatment of first-line mRCC. In calendar year 2009, the drug was Pfizer’s 10th highest-selling biopharmaceutical, with sales of $964 million, up 14% on 2008.

Source: GEN News

Popularity: 5% [?]

A team from NewYork-Presbyterian Hospital/Weill Cornell Medical Center reports that it has figured out why statins work for some people but not for all. Consequently, the researchers believe that their findings also explain why some people on statins are protected against colorectal cancer.

The study is published in the May issue of Cancer Prevention Research. The research team also included scientists from the University of Michigan Medical School, University of Barcelona, NCI, and the Israel Institute of Technology.

The researchers set out to test their hypothesis that people who don’t respond well to the cholesterol-lowering ability of statins also do not benefit from the recently documented protective effects of statins against colorectal cancer. They believed that the difference was in genetic variations that led to a different response to the drug.

They genotyped 40 candidate genes known to be important for synthesis and metabolism of cholesterol in participants of a case-control colorectal cancer study in northern Israel. Included in the 40 genes were six SNPs within the HMGCR gene, which produces a critical enzyme involved in formation of cholesterol. The study’s co-lead author, Steven M. Lipkin, M.D., Ph.D., believes that most statins on the market work by binding to the HMGCR protein.

The study involved 1,780 colon cancer patients and 1,863 people who did not have colorectal cancer. Many of the participants, who were predominantly Caucasian, had used either simvastatin or pravastatin for a long time.

The scientists initially found one SNP within HMGCR that was associated with statin protection against colorectal cancer. A follow-up pharmacogenetic analysis showed that the protective association was significantly stronger among individuals with what they dubbed the “A” SNP allele compared with people who had a “T” variant. The stronger colorectal cancer protection came from individuals with the A/A HMGCR genotype compared with those with the T/T genotype. Individuals with an A/T genotype had intermediate protection against colorectal cancer, with levels varying between that seen for A/A and T/T genotypes.

The investigators then tested, in laboratory colorectal cancer cells, why the T allele might not work well with statins. They found that the protein produced by this HMGCR gene variant does not bind on the statin like the A allele does due to alternative splicing.

“Carriers of the A allele express more of the full-length protein that binds statins and are therefore more sensitive to statins and are more likely to experience the colorectal cancer risk reduction associated with long-term use,” explains Dr. Lipkin. “That is especially true if a person has two A alleles.

“Carriers of the T allele are less sensitive to statins because they are missing part of the protein that binds to statins. A protective effect against colorectal cancer development is largely absent from people who have two T alleles.

“Together, these studies provide strong evidence that these two alleles play an important role in modulation of HMGCR activity for colorectal risk reduction,” Dr. Lipkin says. “We anticipate that genotyping for these alleles in patients may help identify those who are most likely to benefit from statins and spare others who will not respond from any side effects of the drugs.”

Source: GEN News

Popularity: 3% [?]

A number of groups are offering financial aid to cancer patients who can’t cover the costs of treatment, including many who have inadequate health insurance, as I write in the Informed Patient column today.

An estimated 25 million patients are considered underinsured in the U.S — meaning that they have health policies that don’t cover all of their medical needs and leave them struggling with high out-of-pocket cots. And many of their health policies include high deductibles, which can send patients scrambling for aid in the early part of the year before the deductible is met.

Julie Reynes, president of the Patient Access Network, which provides help to patients who can’t meet co-payments for their medications, tells the Health Blog that the group had a “deluge” of requests for help in January and February, but didn’t have adequate funds to help everyone.

The non-profit is one of five major groups that provide such assistance, along with several other disease-specific groups that help patients with cancer co-payments such as the Leukemia and Lymphoma Society. Unless the patient has already incurred the expense, the payments usually go directly to providers, physicians or suppliers of the medications.

A large portion of the funding for co-payment programs is provided by pharmaceutical makers, but as donors, the companies have no say over how the funds are used or which products are used by patients. However, any donations can be directed to a specific disease fund.

Patients can visit the group’s Web site to see which disease funds have monies available. For example, for pancreatic cancer patients, applications for new and renewal patients are being accepted, and grants of as much as $7,500 are allocated immediately. But there’s no funding available at present for colorectal cancer in the program.

Patients who meet eligibility criteria can still be approved and placed on a waiting list and receive assistance once funding becomes available. But Ms. Reynes says one reason for posting the status of the funds is to discourage patients from wasting their time when there isn’t any money to help.

The Patient Access Network Web site also provides links to other groups that provide co-payment help, including the Healthwell Foundation and Patient Services Inc.

Source: The Wall Street Journal

Popularity: 3% [?]

During Celgene’s R&D day tomorrow–the first it has hosted in five years–the developer will attempt to show analysts that it has a promising drug pipeline beyond Revlimid, its top-selling multiple myeloma drug. Revlimid and its predecessor drug Thalomid accounted for almost 80 percent of the biotech’s sales last year. Specifically, Reuters says Celgene will detail its programs for “lung cancer; chemotherapy-induced anemia; multiple myeloma; Crohn’s disease, a gastrointestinal disorder; psoriasis, a skin disorder; and psoriatic arthritis.”

Analysts are also waiting to see if Celgene will produce data supporting Revlimid as a maintenance treatment for multiple myeloma. That could boost the drug’s sales from $1.7 billion in 2009 to $3.8 billion by 2013. The drug is also in clinical trials for chronic lymphocytic leukemia, non-Hodgkin’s lymphoma, prostate cancer and colorectal cancer.

Source: FierceBiotech

Popularity: 3% [?]

Roche’s cancer drug Xeloda enabled elderly patients being treated for colorectal cancer to live free of the disease for longer, the world’s largest maker of cancer drugs said on Thursday.

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A study showed that patients above the age of 65 or 70 years who took Xeloda, or capecitabine, with Xelox, or oxaliplatin, immediately after surgery lived disease-free for longer compared with those treated with commonly used chemotherapy regimen 5-fluorouracil/leucovorin.

In July, Roche said Xeloda, which is already approved for the treatment of early-stage colon cancer as a monotherapy, increased the time patients lived when taken with oxaliplatin, meeting its primary goal in a late-stage trial.

Colorectal cancer is the second most common cause of death from cancer in men and women in Europe, with nearly 1 million cases each year worldwide, said Roche.

Age is the biggest risk factor for the disease and more than 90 percent of cases are diagnosed in individuals over the age of 50, Roche said.

Source: Reuters

Popularity: 4% [?]