EU okays Avastin for breast cancer
The European Union's Committee for Medicinal Products for Human Use (CHMP) has recommended the use of bevacizumab (Avastin) in combination with standard chemotherapy paclitaxel in previously untreated metastatic breast cancer. The decision is based on phase-III-trial data which show that women with metastatic breast cancer have the chance to live twice as long without their cancer progressing if treated with bevacizumab in addition to paclitaxel as against paclitaxel alone. This is the first phase-III study involving an antiangiogenic agent to report positive outcome for patients with metastatic breast cancer.
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"This decision represents a significant milestone, bringing breast-cancer patients and the medical community one step closer to broadly accessing a highly effective new cancer therapy in Europe," said Williams Burns, division chief executive for Roche Pharmaceuticals. "Avastin has shown excellent progression-free survival data in treating this disease and after approval two years ago for first-line treatment of metastatic colorectal cancer, this decision also confirms that Avastin has the potential to become part of the treatment armamentarium for a whole range of tumor types."
Dubbed as E2100, the randomized, controlled, multicenter study enrolled 722 women with previously untreated locally recurrent or metastatic breast cancer. The study was sponsored by the National Cancer Institute, part of the United States National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group.
The results showed that patients receiving bevacizumab plus paclitaxel had a median progression-free survival (PFS) of 13.3 months while patients receiving paclitaxel alone had a median PFS of 6.7 months. PFS is a measure of the time patients live without their disease progressing or dying due to any cause. Overall, patients treated with bevacizumab plus paclitaxel had a 52-percent reduction in the risk of disease progression or death
Additional phase-III trials are ongoing to explore bevacizumab in the first-line treatment of metastatic breast cancer in combination with the chemotherapy docetaxel and other commonly used chemotherapies including Roche's capecitabine, an oral chemotherapy drug. Recently, a phase-III trial in HER-2-positive patients evaluating bevacizumab in combination with trastuzumab and docetaxel was also initiated.
Bevacizumab is the first and only antiangiogenic agent that has been shown to consistently deliver improved overall or progression-free survival benefit for colorectal, lung, breast, and renal-cell cancer patients.
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Diovan lowers stroke, CV events
BASEL, Switzerland
New findings from the independent Jikei Heart Study published April 27 in The Lancet show that adding valsartan (Diovan) to conventional antihypertensive therapy produced a 39-percent reduction in cardiovascular events and a 40-percent reduction in stroke.
The superior benefits reported with valsartan led to an early termination of the study, which involved more than 3,000 Japanese patients.
In addition to its impact on overall cardiovascular events and stroke, valsartan demonstrated relative reductions of 65 percent in angina pectoris (recurring acute chest pain), 46 percent in heart failure, and 81 percent in aortic dissection compared with other treatment modalities. According to the investigators, the benefits cannot be explained by a difference in blood pressure alone. There were few adverse events (2.5-percent overall) with no significant difference in tolerability between the groups.
"The results of this trial carry an important clinical message for physicians across the globe who are trying to protect patients from debilitating complications such as stroke," said Dr. Gordon McInnes, professor of medicine at the Western Infirmary in Glasgow, Scotland. "Jikei Heart tells us that adding Diovan to usual treatment regimens can offer substantial long-term protection."
The Jikei Heart Study is the first controlled trial to assess the cardiovascular benefits of adding valsartan, an angiotensin receptor blocker (ARB) to conventional non-ARB therapy compared with non-ARB therapy alone in a large Japanese population. Key events evaluated as part of the primary end point included heart attack, stroke, and hospitalization for heart failure or angina pectoris.
The study was conceived, designed, and conducted by an investigator-led steering committee representing the Jikei executive committee and the hospitals involved with the trial. The study was funded by the Jikei University School of Medicine in Tokyo with an unrestricted grant from Novartis.
"Innovative clinical trials have helped Diovan to advance cardiovascular patient care," said Dr. Ameet Nathwani, global head of cardiovascular and metabolic clinical research for Novartis Pharma AG. "The results of the independent Jikei Heart Study add to the already large body of evidence demonstrating Diovan's efficacy in lowering blood pressure and preventing cardiovascular events."
The study involved 3,081 people 20 to 79 years old with high blood pressure, ischemic heart disease, or congestive heart failure. The cardiovascular events counted in the combined primary end point of cardiovascular mortality and morbidity were: new or recurrent stroke or transient ischemic attack, hospitalization for congestive heart failure or angina pectoris, heart attack, aortic dissection, lower limb arterial obstruction, doubling of serum creatinine, or transition to dialysis.
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Tykerb for advanced breast cancer
WASHINGTON
The Food and Drug Administration (FDA) approved the targeted anticancer treatment lapatinib (Tykerb) for use together with capectabine (Xeloda) for women with advanced metastatic breast cancer that is HER2 positive. The FDA said tests showed the combination slowed the advance of the cancer.
"[The] approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "New targeted therapies such as Tykerb are helping expand options for patients."
Some 180,000 new cases of breast cancer are diagnosed each year, and annually 8,000 to 10,000 women die from metastatic HER2 breast cancer, the FDA said.
The approval came after a clinical trial on 400 women suffering from advanced HER2-positive breast cancer. The FDA said the study showed a "statistically significant improvement" in the time to tumor progression in the group taking the combination of the two drugs. But they offered no data on survivors after the treatment, saying it was too early to make any determinations.
The FDA said that side effects associated with Tykerb, produced by GlaxoSmithKline, include diarrhea, nausea, vomiting and rash, and numbness, tingling, redness, and swelling in the hands and feet.
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Older TB vaccines protect better
WASHINGTON
Older vaccines used worldwide against tuberculosis could be more effective than the latest versions, according to a new study published in the Proceedings of the National Academy of Sciences.
Researchers at the Pasteur Institute in Paris found multiple genetic mutations in strains of bacillus Calmette-Guerin (BCG), accidentally introduced as the microbe was cultured over decades, reduced the efficacy of the vaccine. They concluded that old and new vaccines should be retested in clinical trials to determine which are the most effective.
"Early BCG vaccines may confer better protection against tuberculosis, a possibility that would benefit from formal evaluation in clinical trials," researchers said.
Researchers looked at the entire genetic sequence of several BCG strains and found changes over time. By studying immune responses in infants, one vaccine strain called BCG Japan, an early strain developed prior to 1925, triggered a more powerful immune reaction than the vaccine strains BCG Danish, BCG Glaxo and BCG Pasteur, which represented 66 percent of the vaccine doses administered in 1996.
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Bonviva lowers risk of fractures
WASHINGTON DC
A new pooled analysis of four major clinical trials presented at the seventh US National Osteoporosis Foundation International Symposium shows that ibandronic acid (Bonviva) significantly reduces the risk of nonvertebral fractures by over a third after two years compared with placebo.
Included in the pooled analysis were four major clinical trials (IV dose fracture study, BONE, MOBILE, and DIVA) involving 8,710 patients with postmenopausal osteoporosis given Bonviva in a range of doses. They were analyzed for occurrence of fractures in the pelvis, hip, clavicle, humerus, wrist, and leg.
Patients were grouped according to doses of ibandronic acid measured by annual cumulative exposure (ACE), which takes into account the bioavailability of the different formulations and allows comparisons of the amount of absorbed drug over a year: 2.0 to 4.0 mg (1,911patients), 5.5 to 7.2 mg (3,585), >10.8 mg (1,290), and 1,924 (placebo).
The group that received the higher annual doses (>10.8 mg), including the clinical marketed doses of 3 mg/3 ml quarterly IV and 150 mg monthly oral, had a 28.8-percent reduction in relative risk for all clinical fractures, 29.9 percent for all non-vertebral fractures, and 34.4 percent for the subgroup of six nonver-tebral fractures. Based on log-rank test, the high ACE group demonstrated a greater time to fracture versus placebo for all clinical fractures (p = .002), and nonver-tebral fractures (p = 0.025) at two years.
Prof. Steven Harris of the University of California in San Francisco and lead author said: "Fracture protection is the most important measure of osteoporosis-treatment efficacy. By pooling data from several different clinical trials, it's possible to gain new insight into the ability of ibandronic acid to reduce fracture risk."
Bonviva previously demonstrated a reduction in the risk of vertebral fractures by 62 percent in BONE (Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe) when dosed at 2.5 mg once daily. While the study was not primarily designed to evaluate the outcome of nonvertebral fractures and the effect was not shown in the overall population, a 69-percent reduction in nonvertebral fractures was demonstrated in a subgroup of high-risk patients. These new data add to the body of evidence supporting the antifracture efficacy profile of Bonviva.
Bonviva, the only once-monthly bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women, received approvals from the European Union in September 2005, the Swiss medic in August 2005, the United States in March 2005, and the Philippines in January 2006.
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Sebivo gets EU nod for hepa B
BASEL, Switzerland
The European Commission has approved telbivudine (Sebivo) as a new first-line treatment for chronic hepatitis B and has been shown to provide rapid and powerful viral suppression within six months of starting therapy.
Approval was based on one-year data from the GLOBE study demonstrating the benefits of telbivudine over lamivudine, the most widely prescribed therapy worldwide, in achieving rapid and powerful suppression of the hepatitis-B virus (HBV).
"Chronic hepatitis B is a serious condition that can lead to cirrhosis, liver cancer, liver failure, and ultimately death," said Dr. Thierry Poynard, professor of medicine and head of the department of hepatogastroenterology, Hôpital Pitié-Salpêtrière, France. "There is no cure for chronic hepatitis B, but high viral load increases the risk of serious complications. To reduce this risk, the goal of therapy is therefore to suppress the hepatitis-B virus as much as possible, and to maintain that decrease over time. The GLOBE study shows that telbivudine does this more effectively than lamivudine."
GLOBE is the largest worldwide registration trial ever conducted in patients with CHB and included 1,367 adult patients at 112 clinical centers in 20 countries. In the European Union, participating countries included the Czech Republic, France, Germany, Greece, Italy, Poland, Spain, and the United Kingdom.
Data from the study indicated that Sebivo works very quickly, suppressing HBV to undetectable levels in more than half of patients at six months, and that 95 percent of them retained their undetectable virus levels at one year. Preliminary two-year results showed that these benefits were maintained through two years of treatment.
"The results of the GLOBE trial showed that the rapid viral suppression achieved with Sebivo at six months can predict outcomes through two years of study," said Dr. James Shannon, global head of development at Novartis Pharma AG. "This is encouraging news for patients and physicians due to the fact that powerful viral suppression, early in the course of treatment, has been shown to be predictive of long-term viral suppression and minimal resistance."
Sebivo delivers this rapid, powerful, and sustained viral suppression with an overall clinical safety profile similar to that of lamivudine. It is given once daily with or without food, helping to ensure better compliance and patient convenience.
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