Navigation Links
FDA Panel Says No to Avastin for Advanced Breast Cancer

Drug has significant risks, and its benefits are still debated, experts say

WEDNESDAY, Dec. 5 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that the cancer drug Avastin should not be used to treat women with advanced breast cancer.

In a close vote, 5-4, the advisers decided the drug's ability to slow down the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users, the Associated Press reported. In rare cases, patients taking Avastin with standard chemotherapy have died.

Avastin was approved to treat colon cancer in 2004, and lung cancer in 2006. It works by cutting off the tumor's blood supply.

"Everybody wants to offer metastic breast cancer patients hope, but we shouldn't offer them false hope," panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the meeting, according to the AP. "We have to raise the bar in terms of safety."

"These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," Maha Hussain, an oncologist at the University of Michigan and the advisory panel's chairwoman, said during the meeting. "You didn't show that patients are living better or that they're living longer."

In trial results submitted to the FDA by the drug's U.S. maker, Genentech Inc., use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same Genentech study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.

Another company-funded trial, this time including 462 patients with advanced breast cancer, showed similar results, with Avastin having no effect on overall survival.

At the same time, the FDA said, the drug has "major safety issues," including hypertension, clotting events, left ventricular heart dysfunction, heart attack, gastrointestinal perforation and proteinuria (excess protein in urine). A special FDA staff review of the data found that rates of grades 3 to 5 toxicities rose by more than 20 percent when cancer patients received Avastin on top of regular chemotherapy.

Furthermore, in the Avastin-paclitaxel trial, the rate of patient deaths linked to Avastin use was 1.7 percent (six out of 363 users) compared to no deaths among the 348 participants who did not receive the drug, the FDA noted.

In its approval submission statement to the FDA, Genentech contended that, "Analysis of the safety and efficacy data in total demonstrates a highly favorable risk-benefit profile for bevacizumab in combination with paclitaxel that supports full approval of bevacizumab for the treatment of locally recurrent and metastatic breast cancer."

The FDA is not obligated to follow the recommendations of its advisory panels, but usually does. A decision is expected by Feb. 23, the AP reported.

Avastin is not traditional chemotherapy, but instead is a monoclonal antibody that robs tumors of their blood supply. It has been found to boost the survival of patients with metastatic colorectal cancer and non-small-cell lung cancer when added to chemotherapy and used as a first-line treatment.

But the drug has its downside. In an analysis of pooled data from five randomized controlled trials involving more than 1,700 patients with metastatic colon, breast or lung cancers, Genetech researchers found that 3.8 percent of patients experienced blood clots while on the drug, compared to 1.7 percent of those who took standard chemotherapy alone.

Patients who were 65 or older appeared to be at special risk for clots while taking Avastin, according to the study, which was published in August in the Journal of the National Cancer Institute.

The exact link between Avastin and cardiovascular risk remains unclear, although the Genentech team speculated that a vascular endothelial growth factor (VEGF), a natural compound that boosts blood vessel growth, may play a role.

More information

Find out more about breast cancer and its treatment at the American Cancer Society.

SOURCES: Dec. 5, 2007, FDA Briefing Document, Oncology Drug Advisory Committee Meeting

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
Related Image:
FDA Panel Says No to Avastin for Advanced Breast Cancer
(Date:10/9/2015)... ... October 09, 2015 , ... With the FCPX LUT Vibrance pack from ... A LUT is a Lookup Table that contains a mathematical formula for modifying an ... table. This pack comes with 60 vibrant CUBE LUT files. , Inspired ...
(Date:10/9/2015)... ... October 09, 2015 , ... Advanced Hearing Solutions, Nashville based ... Toast of Music City, a reader’s choice awards featuring favorite places to shop, ... for their favorite businesses in over 200 categories, including best pizza, best day ...
(Date:10/9/2015)... ... October 09, 2015 , ... On Saturday, September 26, ... Jump Rope Championship in Madrid, Spain. Representing both the USA and Sweden in the ... Unders and One-Minute Am Front Crosses, she was awarded 1 Silver and 4 Gold ...
(Date:10/9/2015)... ... October 09, 2015 , ... "As a nurse, I care ... Philadelphia, Pa. "They have to wear large diapers or pads. We came up with ... the TROUSAFE to absorb urine leaking from the tip of the penis. This prevents ...
(Date:10/9/2015)... ... October 09, 2015 , ... Santa Rosa Consulting and The ... MD Anderson prepares to go-live on the Epic platform in March of 2016. Both ... Santa Rosa will execute the contract by supporting Scheduling Appointment Conversion and the Go-Live. ...
Breaking Medicine News(10 mins):
... Reporter , MONDAY, Feb. 14 (HealthDay News) -- Obesity and ... of an average of 3.5 years of life in which ... pain, new research finds. Some 40 percent of older ... an often painful and potentially disabling condition that can be ...
... 300-year ancestry of deaf people in America, Richard C. Pillard, ... Medicine (BUSM) and his co-authors argue that deaf people who ... group. The book, "The People of the Eye: Deaf ... people who identify themselves as members of Deaf-World and compares ...
... News) -- Smoking may increase the risk of the fatal ... year in the United States, more than 5,500 people are ... is no cure for the disease and treatments are very ... long-term studies that involved a total of more than 1.1 ...
... HealthDay Reporter , MONDAY, Feb. 14 ... with attention-deficit hyperactivity disorder may reveal insights into ... according to two new studies. In joint ... and the Kennedy Krieger Institute in Baltimore performed ...
... cancer, approximately 25% have a subtype that is characterized ... HER2-positive breast cancer tends to be more aggressive than ... HER2-positive breast cancer is so aggressive could aid in ... a team of researchers, led by Lewis Chodosh, at ...
... This release is available in French . ... Engineering Research Council of Canada (NSERC) awarded 12 prizes ... than C$1 billion, the federal granting agency is the ... Artificial intelligence and machine learning pioneer Geoffrey Hinton was ...
Cached Medicine News:
(Date:10/9/2015)... Ontario , Oct. 9, 2015 /PRNewswire/ ... radiology furniture, monitor mounting solutions and reading ... Hospital,s Department of Pediatric Radiology realize their ... RedRick Technologies provided ergonomic design guidance and ... clinical collaboration and teaching. George ...
(Date:10/9/2015)... , October 9, 2015 ... --> The report summarizes key ... overall status of the manufacturers making ... and direction for companies and individuals ... . --> ...
(Date:10/9/2015)... PHILADELPHIA , October 9, 2015 ... Conference, Oct. 7-9   ... information products and services, today launched ClinicalKey for Nursing ... authoritative content, tailored to meet the unique needs of nursing ... in Atlanta , Oct. 7-9, will have ...
Breaking Medicine Technology:
... CeQur SA, a company focused on the development ... management of type 2 diabetes, announced the appointment of ... directors, effective immediately. , Milledge is a 34-year ... recently served as company group chairman of Lifescan Inc., ...
... , PITTSBURGH, Oct. 6 Foundation Radiology Group ... services, headquartered in downtown Pittsburgh, recently added Shawn ... growing staff. , Kramer, a 20-year client services ... AT&T Wireless Services, Ceridian, and XO Communications. , ...
Cached Medicine Technology:
Indications For Usage: ,Adult (recommended tidal volume >150ml), single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended to ...
Indications For Usage: ,Adult (recommended tidal volume >150ml), single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended to ...
... The Portex® Thermovent® T helps provide protection ... It is small and extremely lightweight making it ... adults. With a high rate of heat and ... secretion retention., ,All HMEs and filters have ...
... helps provide protection to the exposed airway of ... lightweight making it ideal for active young children ... of heat and moisture recovery, it ensures patient ... and filters have ISO standard tapered ends to ...
Medicine Products: