June 28, 2011 |
Whether the cancer drug Avastin should be revoked as a treatment for advanced breast cancer is the subject of both passion and debate. Some breast cancer patients and doctors desperately want the drug to remain available; the FDA is holding hearings on the matter Tuesday and Wednesday. The drug’s maker, Genentech, seeks to convince an FDA panel that Avastin’s benefits outweigh its risks. The FDA isn’t yet convinced . The back-and-forth on the drug’s approval has been a rare challenge to the FDA’s authority to judge the effectiveness and safety of a drug, as a CNN article notes.
June 4, 2011 |
The widely used cancer drug Avastin may benefit women with ovarian cancer, both those who are newly diagnosed and those in whom the disease has recurred after initial treatment, researchers reported Saturday at a Chicago meeting of the American Society of Clinical Oncology. For ovarian cancers treated early in the course of the disease, the drug reduced the risk of death. For recurrent cancers, the drug delayed progression but the improvement in survival did not quite reach statistical significance, researchers said.
April 28, 2011 |
The cancer drug Avastin may work just as effectively as the more expensive Lucentis at treating age-related macular degeneration, new research suggests. But the potential side effects bear watching. The early results of a clinical trial comparing the two drugs was published online Thursday in the New England Journal of Medicine , slightly ahead of schedule. Avastin doesn’t have FDA approval to treat AMD -- it’s approved to prevent the growth of blood vessels that fuel tumors.
February 1, 2011 |
Avastin, a popular cancer drug that slows the growth of some types of tumors, may also be linked to an increased risk of death, new research suggests. A study published Tuesday in the Journal of the American Medical Assn. reviewed randomized controlled clinical trials from 1966 to 2010 with a total of 10,217 patients. FOR THE RECORD : An earlier version of this post said the FDA withdrew approval of Avastin for breast cancer patients in December. In fact, the FDA moved to begin the process of withdrawing approval.
December 22, 2010
A rule for rainy days Re "Storms line up to pelt region," Dec. 20 Now that our rainy season has arrived with a vengeance, perhaps it's time to remind both motorists and, apparently, local police forces that a state law passed a few years ago requires headlights to be on if your windshield wipers are. It's common-sense traffic safety: Rain-spattered side windows make unlit cars disappear as they pull up or change lanes behind and...
December 18, 2010
The Food and Drug Administration has reversed course on Avastin, recommending this week that the popular tumor inhibitor no longer be promoted as a safe and effective treatment for advanced breast cancer. The ruling drew howls from some patient advocates and many Republicans, who accused the Obama administration of trying to cut healthcare costs at the expense of cancer patients. Such criticisms are overblown; the Avastin decision was based on the drug's poor performance in follow-up studies, not some callous cost/benefit analysis.
December 17, 2010 |
The Food and Drug Administration took steps Thursday to withdraw its approval for use of Avastin as a breast cancer drug after citing clinical trials that failed to show that Avastin prolonged life among breast cancer patients. The decision drew sharp and quick reactions. This Los Angeles Times story reports: "One of those opponents, Sen. David Vitter (R- Louisiana), noted that if the FDA removed its imprimatur, Avastin, which costs thousands of dollars per month, would only be available through so-called "off-label" prescribing and thus not covered by most insurance.
December 16, 2010 |
Avastin hasn't proved to be a safe and effective treatment for breast cancer patients, and the U.S. Food and Drug Administration has taken steps to withdraw approval of Avastin for such treatment, an FDA statement released Thursday says. The FDA action on Avastin, known generically as bevacizumab, isn't all that surprising. This Los Angeles Times article reports that an advisory panel in July recommended withdrawing approval for breast cancer treatment. The FDA statement says in part: "The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
December 16, 2010 |
The Food and Drug Administration moved Thursday to withdraw approval of the blockbuster drug Avastin for breast cancer patients because four recent studies showed it does not extend their lives. FOR THE RECORD: Avastin: A Dec. 17 article in Section A about the Food and Drug Administration's move to withdraw approval of the drug Avastin for breast cancer patients quoted Diana Zuckerman, president of the National Research Center for Women and Families, as saying, "The evidence is clear.
November 14, 2010 |
Question: I have heard many good things about Roche Holding. Is it a good investment in light of the new healthcare law? Answer: This Swiss pharmaceutical firm has lost some investment luster. The company has an array of cancer-fighting biotechnology drugs, but its once-robust sales growth has been slowing, the threat of cheaper generic drugs is growing, and the company has suffered setbacks in drug development. To improve its outlook, the company is turning to cost-cutting, with staff reductions expected in a number of markets.