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Avastin No Benefit to Older Lung Cancer Patients: Study
Posted 17 Apr 2012 by Drugs.com
TUESDAY, April 17 – Medicare patients who have advanced non-small cell lung cancer appear to get no survival benefit from adding the drug Avastin to standard chemotherapy, researchers from the Dana-Farber Cancer Institute report. An earlier trial had found that Avastin (bevacizumab) did improve survival, but not in patients aged 65 and older. Even so, the researchers noted, most patients diagnosed with non-small cell lung cancer are 65 and older and Medicare still covers the cost of the drug. "A drug that we were just ecstatic about in 2006, we have to be more circumspect about," said lead researcher Dr. Deborah Schrag, an oncologist at Dana Farber, in Boston. Avastin should be used judiciously, she added, noting that "older patients should discuss it with their doctors, but we cannot say it provides a survival advantage based on these data." However, Schrag does not think Medicare ... Read more
Related support groups: Avastin, Non-Small Cell Lung Cancer, Bevacizumab
FDA Medwatch Alert: Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient
Posted 4 Apr 2012 by Drugs.com
ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey). BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered cou ... Read more
Related support groups: Avastin, Bevacizumab
FDA Medwatch Alert: Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices
Posted 15 Feb 2012 by Drugs.com
ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing ou ... Read more
Related support groups: Avastin, Bevacizumab
Avastin May Be Helpful Before Breast Cancer Surgery
Posted 25 Jan 2012 by Drugs.com
WEDNESDAY, Jan. 25 – The addition of the cancer-fighting medication Avastin to chemotherapy prior to breast cancer surgery increases the chance that all of the cancer will be removed, according to new research. However, when looking at which patients might benefit the most from this therapy, two recent studies found conflicting results, and neither study was yet able to address whether or not the addition of Avastin (bevacizumab) early in the treatment process would improve survival rates. Information on survival will be especially important for defining Avastin's role in early breast cancer treatment. That's because in November 2011, the U.S. Food and Drug Administration (FDA) revoked Avastin's approval for the treatment of breast cancer that has spread to other parts of the body. With metastatic breast cancers, the agency felt the survival benefits were lacking, and the drug carries ... Read more
Related support groups: Breast Cancer, Avastin, Bevacizumab
Avastin May Help Some With Ovarian Cancer: Studies
Posted 28 Dec 2011 by Drugs.com
WEDNESDAY, Dec. 28 – Two new studies suggest that the drug Avastin may lengthen progression-free survival by about four months for women with ovarian cancer. What isn't clear yet is whether adding Avastin (bevacizumab) will make a difference in overall survival. One study suggested it would, while the other study didn't find a difference in overall survival between two treatment groups. "The bottom-line results are a 28 percent reduction in disease progression with patients on continued bevacizumab compared to the standard treatment group. There was a 3.8 month median difference in progression-free survival," said Dr. Robert Burger, author of one of the studies and director of the Women's Cancer Center at Fox Chase Cancer Center in Philadelphia. "We still have to fine-tune or optimize this sort of new paradigm of treatment. This regimen [chemotherapy plus continued Avastin] could be ... Read more
Related support groups: Avastin, Ovarian Cancer
Avastin May Help Some With Ovarian Cancer: Studies
Posted 28 Dec 2011 by Drugs.com
WEDNESDAY, Dec. 28 – Two new studies suggest that the drug Avastin may lengthen progression-free survival by about four months for women with ovarian cancer. What isn't clear yet is whether adding Avastin (bevacizumab) will make a difference in overall survival. One study suggested it would, while the other study didn't find a difference in overall survival between two treatment groups. "The bottom-line results are a 28 percent reduction in disease progression with patients on continued bevacizumab compared to the standard treatment group. There was a 3.8 month median difference in progression-free survival," said Dr. Robert Burger, author of one of the studies and director of the Women's Cancer Center at Fox Chase Cancer Center in Philadelphia. "We still have to fine-tune or optimize this sort of new paradigm of treatment. This regimen [chemotherapy plus continued Avastin] could be ... Read more
Related support groups: Avastin, Ovarian Cancer
Avastin Boosted Survival for Type of Aggressive Breast Cancer: Study
Posted 7 Dec 2011 by Drugs.com
WEDNESDAY, Dec. 7 – In November, the U.S. Food and Drug Administration revoked its approval of the drug Avastin for the treatment of breast cancer. But, a new study suggests that the drug can boost the survival of women with a specific type of aggressive breast tumor when used in conjunction with two other medications. Avastin (bevacizumab) had been approved in the United States in 2008 as a treatment for metastatic breast cancer – cancer that has spread to other parts of the body. It was used with chemotherapy to treat a type of breast tumor called HER2-negative. Even though the FDA withdrew that approval, Avastin is still approved to treat some other types of cancers. Doctors may legally prescribe the drug to treat breast cancer, although insurers may refuse to cover it. According to the FDA, the benefits of Avastin use for breast cancer do not justify the risks, which may include ... Read more
Related support groups: Breast Cancer, Avastin
FDA Revokes Approval of Avastin for Breast Cancer
Posted 18 Nov 2011 by Drugs.com
FRIDAY, Nov. 18 – Saying the risks outweigh the benefits in patients with advanced breast cancer, U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg said on Friday that the agency has rescinded its approval of the cancer drug Avastin for that use. Avastin (bevacizumab), however, will remain available for treating some types of colon, lung, kidney and brain cancer. "Today, I am revoking the FDA's approval of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use," Hamburg said during a late morning press conference. "Sometimes, despite the hopes of investigators, patients, industry, and even the FDA, the results of rigorous testing can be disappointing," she said. "This is the case with Avastin when used for the treatment of metastatic breast cancer." The risks of Avastin include severe high blood ... Read more
Related support groups: Breast Cancer, Avastin, Bevacizumab
Cancer Patients Should Ask Doctors to Use Simple Terms
Posted 28 Sep 2011 by Drugs.com
WEDNESDAY, Sept. 28 – Cancer patients are often faced with many difficult-to-understand treatment choices that can have serious side effects and even mean the difference between life and death. That's why it's crucial that patients insist doctors use plain language in explaining the options, advised Angela Fagerlin, an associate professor of internal medicine at the University of Michigan Medical School and a researcher at the U-M Comprehensive Cancer Center. "People are making life and death decisions that may affect their survival and they need to know what they're getting themselves into. Cancer treatments and tests can be serious. Patients need to know what kind of side effects they might experience as a result of the treatment they undergo," Fagerlin said in a university news release. She and her colleagues outlined a number of tips to help patients get the information they need ... Read more
Related support groups: Cancer, Methotrexate, Provera, Breast Cancer, Lupron, Accutane, Depo-Provera, Prostate Cancer, Tamoxifen, Femara, Arimidex, Lupron Depot, Medroxyprogesterone, Claravis, Gleevec
Avastin Rejection Supported by Cancer Experts
Posted 1 Jul 2011 by Drugs.com
FRIDAY, July 1 – Oncologists and even some breast cancer support groups are endorsing a U.S. health advisory panel's recommendation that the blockbuster cancer drug Avastin be removed for use in metastatic breast cancer. The reason: There's still a lack of understanding of how the drug works or who it helps. Avastin was given fast-track approval by the U.S. Food and Drug Administration in 2008 to be used, in combination with the chemotherapy drug Taxol, by women with metastatic HER2-negative breast cancer. But a six-member FDA panel of cancer experts said Wednesday that the drug was not effective, caused dangerous side effects and its approval should be revoked. The decision, which is non-binding, came at the end of a two-day hearing granted to Avastin maker Genentech after the FDA recommended last December revoking the drug's approval for metastatic breast cancer. The FDA cited the ... Read more
Related support groups: Breast Cancer, Avastin
FDA Panel Rejects Avastin for Breast Cancer
Posted 29 Jun 2011 by Drugs.com
WEDNESDAY, June 29 – The blockbuster cancer drug Avastin got soundly rejected late Wednesday as a treatment for metastatic breast cancer by a United States health advisory panel that found the medication was not effective and causes dangerous side effects. By unanimous vote, the panelists rejected the drug maker's appeal of a U.S. Food and Drug Administration recommendation last December to revoke Avastin's approval for breast cancer. The FDA recommendation cited the medication's poor performance in follow-up studies and its potential for serious side effects. The drug maker, Genentech, now owned by pharmaceutical giant Roche, was given an unusual two-day hearing this week before the six-member advisory group. Tuesday's opening-day hearing was dominated by patients and physicians who argued, often emotionally, against the drug's revocation. "For the patients and their supporters, it ... Read more
Related support groups: Breast Cancer, Avastin
FDA to Hear Appeal on Breast Cancer Drug
Posted 28 Jun 2011 by Drugs.com
TUESDAY, June 28 – The controversial cancer drug Avastin becomes the focus of U.S. regulators' attention again Tuesday during a two-day hearing to determine if the medication can keep its FDA approval for the treatment of metastatic breast cancer. Back on Dec. 16, the U.S. Food and Drug Administration recommended revoking approval of the drug to fight breast cancer, citing the medication's poor performance in follow-up studies and its potential for serious side effects. The drug's maker, Genentech, now owned by the pharmaceutical giant Roche, was given the chance to appeal the FDA recommendation and present additional evidence. That appeal will be the focus of the hearing and, according to published reports, will involve Genentech urging one more clinical trial before any government action on the drug. The FDA's unusual step of scheduling another hearing on the drug underscores the ... Read more
Related support groups: Avastin, Breast Cancer, Metastatic
Chemo for Late-Stage Cancer Patients May Be Unjustified
Posted 9 Jun 2011 by Drugs.com
THURSDAY, June 9 – Some patients with advanced cancer receive drugs that won't help them but could cause them harm, a U.S. study suggests. University of Chicago researchers analyzed medical and pharmaceutical claims from 1,041 patients with metastatic colon cancer who were treated between January 2007 and June 2010. Of those patients, about one in eight received chemotherapy treatments that weren't supported by evidence from clinical trials or by clinical practice guidelines. The researchers focused on three specific treatments. One had insufficient data to support its use, one had been shown to be ineffective, and one was not supported by data or a compelling rationale, according to the study. The treatment with insufficient data involved the use of Avastin (bevacizumab) after a patient's cancer had progressed despite treatment with a combination of the drug and chemotherapy. The ... Read more
Cancer Drug Avastin Makes Inroads Against Ovarian Tumors
Posted 5 Jun 2011 by Drugs.com
SATURDAY, June 4 – Two new studies indicate that a common cancer drug, Avastin, may benefit both early stage ovarian cancer patients and women whose cancer has recurred. In both studies, presented Saturday at the annual meeting of the American Society of Clinical Oncology in Chicago, Avastin (bevacizumab) was added to standard chemotherapy. But the high cost of Avastin (as much as $6,000 a month) could be prohibitive, especially given that other therapeutic options are available to women in each group, said Dr. Kristine Zanotti, a gynecologic oncologist with University Hospitals of Cleveland. "This is interesting but not practice-changing," she said. Zanotti was not involved with the research. According to the American Cancer Society, ovarian cancer is the fifth most common cancer among women, but it is especially deadly because it is often caught too late for effective treatment. ... Read more
Related support groups: Avastin, Ovarian Cancer
More Evidence Cancer Drug Avastin May Cause Harm
Posted 2 Feb 2011 by Drugs.com
TUESDAY, Feb. 1 – A new review finds more evidence that the beleaguered cancer drug Avastin may harm patients. An analysis of previously published studies found that the drug, when used in combination with chemotherapy or biological therapy, actually increased patient deaths from adverse events, compared with using chemotherapy or biologics alone. This new information should change the way patients and practitioners think about the drug, said Dr. Shenhong Wu, senior author of the report, published Feb. 2 in the Journal of the American Medical Association. "I believe the risk-benefit ratio has changed," said Wu, assistant professor of medicine at Stony Brook University Medical Center in Stony Brook, N.Y. "Physicians need to think about this." Avastin (bevacizumab) was okayed in 2008 for use in conjunction with chemotherapy to treat breast cancer under the U.S. Food and Drug ... Read more
Related support groups: Avastin
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Macular Degeneration, Pancreatic Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Colorectal Cancer, Glioblastoma Multiforme, Breast Cancer, Renal Cell Carcinoma, Neurofibromatosis, Solid Tumors, Breast Cancer, Metastatic, Malignant Glioma