Navigation Links
FDA Panel Says No to Avastin for Advanced Breast Cancer
Date:12/5/2007

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:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Says No to Avastin for Advanced Breast Cancer
(Date:4/24/2017)... ... April 24, 2017 , ... The Santana Telehealth Project was honored with the ... the American Telemedicine Association’s annual conference, on April 23 in Orlando, FL. , “I ... improve the lives of the poor and underserved in other parts of the world,” ...
(Date:4/24/2017)... ... ... As part of the nationwide Days of Remembrance effort led by the ... Nazi persecution, Center for Medicine after the Holocaust (CMATH) announced that it ... Germany and Poland next week. , The Fourth Biennial CMATH Champions Trip to Germany ...
(Date:4/24/2017)... ... ... The bar for just about everything—apparel, eyewear, cars and even phone cases—is ... and film stardom.(1) Not to be left out is that most desired of commodities, ... gamut from being encrusted with jewels and precious metals to, at the very least, ...
(Date:4/24/2017)... ... April 24, 2017 , ... The California Dental Association Foundation’s two-day volunteer dental ... 1,961 people during the April 22-23 event at the San Mateo Event Center. ... barriers to care, CDA Cares educates the public and policymakers about the importance of ...
(Date:4/24/2017)... ... April 24, 2017 , ... Veteran Theresa James awoke to the ... life forever. , In “Healing Tears,” James depicts every parent’s worst nightmare, when her ... I began journaling conversations and situations throughout my divorce,” James said. “After the death ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... India , April 19, 2017 ... and Application, Forecast to 2022 report has covered and analysed ... statistics and information on market size, shares and growth factors. ... major drivers, challenges and opportunities in the global market. ... Browse 152 Tables and Figures, ...
(Date:4/19/2017)... 2017  Novartis today announced the publication of ... and Blood Institute (NHLBI) of the National Institutes ... with treatment-naïve severe aplastic anemia (SAA) achieved complete ... at the initiation of and concurrently with standard ... sequential treatment groups, or cohorts. Cohort 3 added ...
(Date:4/18/2017)... DALLAS , April 18, 2017 Viverae ... proud to announce the integration of IBM ® ... platform to deliver targeted communications for a personalized experience. ... meaningful actions on their health in real time. The ... that matter most to members, wherever they are in ...
Breaking Medicine Technology: