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 Phase III trial which showed that median overall survival was 11.2 months when patients continued Avastin along with the second-line chemotherapy, compared to a 9.8-month median survival with just the second-line chemotherapy without Avastin. Participants in the trial averaged about 63 years old, and were able to carry out normal activities or at least housework or office work (i.e., ECOG performance status of 0-1).

There was no significant increase in adverse events (such as worse side effects) in those continuing Avastin, versus those who stopped the drug for second-line treatment.

FDA approval for the new use clears the way for insurers to cover the drug’s use, which averages roughly $5,100 a month.

Sources: Jan. 25, 2013 FDA press release; “Avastin Wins New Colorectal Cancer Indication,” Jan. 24 2013 MedPage Today ; “Genentech’s Avastin approved for wider use in colorectal cancer,” Jan. 24 San Francisco Business Times.

Disclosure: Fight Colorectal Cancer accepts  unrestricted educational grants and charitable donations from Genentech, the manufacturers of Avastin. Fight Colorectal Cancer has ultimate control over website content.

By Curt Pesman and Mary Miller

In an unusual move, sanofi pharmaceutical company has instituted a 50 percent discount, effective immediately, on its latest cancer drug Zaltrap.  The reason for the sharp price drop, company officials said, was “market resistance” to the initial price.

Zaltrap was approved in August by the FDA for second-line treatment for metastatic colorectal cancer.

One possible result of the price cut is that the new drug may become more widely available. However, due to complex pricing and regulation issues, it’s not yet known how the actual cost to patients will change over the next several months. Fight Colorectal Cancer is gathering more information today on this issue from oncologists and company officials. Read the rest of this entry »

Circulating tumor cells (rare cells from a cancerous tumor that appear in the bloodstream) can help predict how a person with metastatic colorectal cancer (mCRC) might do over time.

A study published in the October 2012 Annals of Oncology compared levels of CTCs with levels of CEA (carcinoembryonic antigen) to see how the two tests compared or could be used together to predict survival times in metastatis CRC.

Results in 217 patients with metastatic CRC showed that at the beginning of treatment, CTC numbers alone–not CEA levels–could accurately predict length of survival. But when patients had a high initial level of CEA levels, adding the CTC number helped predict which patients would survive longer. At the 6-12 week mark, each test alone could accurately predict prognosis.   

The study’s second author and member of FCRC’s Medical Advisory Board, Dr. Neal Meropol, noted that, in clinical practice, he tends to rely more on CT scans and MRIs for metastatic CRC treatment decisions, but that CTCs seem to be a good indicator for overall prognosis. Read the rest of this entry »

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 $11,063 on average for a month of treatment—is more than twice as high.” Read the rest of this entry »

Photo credit: Bayer Pharmaceuticals

The FDA today approved the use of the drug regorafenib (brand name Stivarga) for patients whose metastatic colorectal cancer has progressed despite all currently approved treatment regimens.

This is the second new drug approved by the FDA recently after a drought of 5 years in approving new treatments for metastatic colorectal cancer (mCRC). Regorafenib was placed into the  FDA’s “fast-track” approval process after the international, multicenter Phase III CORRECT trial  showed improved survival (from 5 to 6.4 months) in all mCRC patients, including those having both non-mutated and mutated KRAS types. Read the rest of this entry »