Tag Archives: bevacizumab

FDA Approves Avastin for New Second-Line Use

For patients with metastatic colorectal cancer, the Food and Drug Administration (FDA) has approved a new use of Avastin® (bevacizumab): It can be continued as part of ‘second-line’ combination therapy, even if it was used in first-line therapy. When stage IV cancer progresses despite use of Avastin plus either FOLFOX (5FU plus Eloxatin® or oxalyplatin) or FOLFIRI (5FU plus Camptosar® or irinotecan)-based chemotherapy, the FDA has now approved continued use of Avastin when second-line treatment switches to the other chemotherapy. Avastin is a monoclonal antibody (a “targeted drug”) that helps prevent a cancer from stimulating growth of new blood-vessels that then help the tumor get bigger. The FDA’s approval is based on a large, randomized

Memorial Sloan-Kettering Will Not Offer Zaltrap

Memorial Sloan-Kettering Cancer Center made a very public announcement—and explanation—today in a New York Times op-ed about why they will not offer the new drug Zaltrap® (ziv-aflibercept) to its metastatic colorectal cancer patients. The authors, all world-renowned cancer specialists at the world’s oldest cancer center, in an op-ed headlined “In Cancer Care, Cost Matters,” essentially challenged other cancer centers to take action where politicians fear to tread. “We recently made a decision that should have been a no-brainer,” wrote Drs. Peter B. Bach, Leonard B. Saltz and Robert E. Wittes. “The drug, Zaltrap, has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price—at

FDA Avastin Breast Cancer Decision Doesn't Impact Colorectal Cancer Treatment

Although FDA Commissioner Margaret Hamburg announced a final decision on November 18 to drop breast cancer from the Avastin label, metastatic colorectal cancer continues to be an approved use. The Avastin® (bevacizumab) label includes the following approved indication: Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment. It is important to know that there is currently no approval or evidence for using Avastin alone or in early stage colon or rectal cancer.

FDA Avastin Breast Cancer Decision Doesn’t Impact Colorectal Cancer Treatment

Although FDA Commissioner Margaret Hamburg announced a final decision on November 18 to drop breast cancer from the Avastin label, metastatic colorectal cancer continues to be an approved use. The Avastin® (bevacizumab) label includes the following approved indication: Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment. It is important to know that there is currently no approval or evidence for using Avastin alone or in early stage colon or rectal cancer.

FDA: Avastin Can Cause Ovarian Failure

The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including Loss of ovarian function (ovarian failure). Bone death in the jaw (osteonecrosis). Bleeding and additional blood clots in patients who have already had a clot in their veins while on Avastin. Changes to the Avastin label were announced on September 30, 2011.

Highlights from ASCO 2011

While there weren’t new blockbuster announcements for colorectal cancer this year at the American Society for Clinical Oncology’s (ASCO) Annual Meeting, there was plenty of focus on making what we already have work better and on choosing the patients who will benefit the most from treatments, as well as those who might not be helped at all. (Note, many of these issues will be discussed in detail on our upcoming patient webinar.) Highlights: While adding oxaliplatin to 5-FU improves five year survival slightly for stage II colon cancer, it increases side effects, particularly tingling and numbness in the feet.  An analysis of several NSABP trials found that two or three

Leading GI Cancer Researcher Updates Patients

Last night, Dr. Edith Mitchell of Thomas Jefferson University Kimmel Cancer Center in Philadelphia, PA, updated colorectal cancer patients on the latest research and treatment news in an online webinar. Dr. Mitchell highlighted the most important news for colon and rectal cancer patients to come from the 2011 Gastrointestinal Cancers Symposium held in San Francisco last month. She answer such questions as… “Can doctors determine the chances that my cancer may return?” “Can my doctors determine if I need chemotherapy?” “Does Avastin or Erbitux benefit my stage III cancer treatment?” “Are there any promising new treatments on the horizon?”

AVANT Says No Avastin Benefit in Stage III Colon Cancer

A second randomized clinical trial has confirmed what the first one found — adding Avastin to standard chemotherapy does not reduce recurrences after surgery for stage III colon cancer. The AVANT trial compared standard FOLFOX chemotherapy to either FOLFOX plus Avastin® (bevacizumab) or XELOX plus Avastin.  Chemo was given for 6 months, and Avastin was added during that time and for another 6 months after chemo ended. Nearly 2,870 stage III patients took part in the study. Like in the C-08 trial, there was a temporary benefit during the year that patients got Avastin, but it didn’t last.  By the end of three years the percentage of people who were

Second Avastin Trial Shows No Benefit in Early Stage Colon Cancer

Adding Avastin® (bevacizumab) to chemotherapy for early stage colon cancer didn’t reduce the risk that cancer would return. In fact, preliminary results of the AVANT trial found that chemotherapy alone worked better in preventing recurrences of stage III and high-risk stage II colon cancer, according to a news release from Roche, sponsors of the international clinical trial. This is the second trial in which adding Avastin to chemotherapy after surgery for early stage colon cancer failed to show a disease-free survival benefit.  The C-08 trial found that, although Avastin did improve disease-free survival during the first year of treatment, the benefit had disappeared by the third year. The results of

Afinitor Combined with Avastin Promises Help for Advanced Colorectal Cancer

Some colorectal cancer patients whose tumors had gotten worse on all standard treatments benefited from a combination of Afinitor® (everolimus) and Avastin® (bevacizumab) during a small trial reported at the 2010 ASCO Annual meeting in Chicago. While no tumors got smaller on the treatment, about half of patients in the Phase II trial had their cancer remain stable for six months or more.  Three patients have had stable disease for more than a year. Seven out of ten patients in the trial had at least one serious side effect.  The most common was hypertension, but there were several bowel abscesses or fistulas and one case of bowel perforation.  There was

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