HOT NEWS--Genentech gets FDA approval for avastin for breast cancer!

[Lani]

http://www.iht.com/articles/2008/02/22/business/22drugFW.php

[hutchibk]

I had a feeling in San Antonio, when hearing a couple of the good docs there speak about the 5-4 "NO" vote by the advisory panel (which happened just before SABCS) that the FDA would wisely look deeper and listen closer to the clinical practioners who were using it... and so they did. This is good news for those who are depending on Avastin.

[madubois63]

Another article was posted on AOL this morning. I couldn't open your article, but will keep trying. Thanks for posting.

http://money.aol.com/news/articles/_a/avastin-okd-to-treat-breast-cancer/20080222181809990001?ncid=NWS00010000000001

Avastin OK'd to Treat Breast Cancer

By MATTHEW PERRONE,
AP
Posted: 2008-02-22 20:39:11
WASHINGTON (Feb. 22) - A drug made by Genentech received federal approval on Friday to treat breast cancer, a decision that could represent a major shift in standards for assessing the effectiveness of cancer medicines.

Going against the recommendation of its advisory panel, the Food and Drug Administration cleared Genentech's Avastin, which is already approved for treating lung and colon cancer, based on findings that it slowed tumor growth.

Advocates for breast cancer patients applauded the ruling. Genentech said FDA granted the drug preliminary approval and the company will have to submit additional data.

FDA approval for late-stage cancer treatments is usually contingent upon data showing a drug extended, or improved the quality of, patients' lives. Avastin showed neither in a study, according to Genentech's application. Instead Genentech showed that the drug slowed tumor growth, without actually increasing life expectancy. Cancer experts have long debated whether that measure is as significant as survival rates for measuring a drug's effectiveness. Wall Street analysts believe FDA's Avastin decision opens the door for other cancer drugs to be approved for their tumor-shrinking capabilities - a trend that worries some health experts. "If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint," said Dr. Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University.

The questions surrounding Avastin's effectiveness have caused debate among cancer experts, doctors and patients. In December, a panel of outside FDA advisers voted 5 to 4 against Genentech's application, indicating the drug's benefits did not outweigh toxic side effects. Despite the panel's narrow recommendation against the drug, many U.S. doctors continued prescribing it "off-label," or without a federal endorsement, for breast cancer. Genentech has previously estimated that more than 9,000 breast cancer patients receive the drug this way. Some insurers have been reluctant to pay for the injectable drug, which can cost $100,000 for a year's supply. Dr. Joseph Sparano said he prescribes Avastin because it has shown better results at slowing breast cancer growth than any other drug on the market. The Y-Me National Breast Cancer Organization called Avastin an important new option for patients.
"The benefits we're looking at with Avastin matter because they give patients hope," said Margaret C. Kirk, the group's president. "Without disease progression they may survive to see a discovery that can help them in the future."

Copyright 2008 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.

2008-02-22 18:18:38

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<!-- MOD: mod_trricomment - 260808 --><script language="javascript" type="text/javascript" src="http://my.screenname.aol.com/_cqr/login/checkStatus.psp"></script><script language="JavaScript"> <!-- var sitedomain = "channel.aol.com"; var authLev = "1"; var _sns_bg_color_ = "CFD9E3"; var _sns_x_offset_ = 0; var _sns_y_offset_ = 0; var _sns_showSignInOutLinks_ = 0; var _sns_showByDef_ = 1; var _sns_set_var_ = 1; var _sns_var_ = ""; var siteState = encodeURIComponent("OrigUrl="+encodeURIComponent(window.location)); -->*</script>My comments to this post:

The following quote is the WORST words ever written:
"If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint," said Dr. Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University."

As a THREE time survivor of breast cancer and a ONE time survivor of Acute Myeloid Leukemia, believe me...survival IS the most important endpoint especially if it is progression free!! I will NEVER forget that, and I doubt very highly that anyone facing cancer would. There is NO cure for cancer YET. Every morning I wake up, I REMEMBER to survive this day until the day that a cure is found.

Humans are not that good at keeping secrets! If there was a cure, it would be on the market by now - AT A VERY EXPENSIVE PRICE! angelmjanine: I am sure you heard the oncologist right, but just remember Elvis keeps getting spotted all around America...People say things for notoriety and far less reasons.

According to the medical profession, after my successful bone marrow transplant, I am considered cured. Then why do I keep getting checked every 2 months??? Because doctors can't cure ANYTHING - only luck, chance, God, Buddha, Ra...who ever you believe in or pray too can...Oh, and the bone marrow transplant that "cured the leukemia didn't cure the breast cancer...it's back. I am not taking Avistan at this time, but I am comforted to know another drug is in my arsenal should I need it. I would have taken it off label anyway!!

AS AN EXTRA NOTE AFTER READING OTHER POSTS: the leukemia was caused by chemo for the breast cancer...but I would do it over again knowing what I know because I am still here. If I needed to get leukemia to survive the breast cancer then so be it...

http://presence.webmail.aol.com/mailsig/?sn=madubois63 (http://presence.webmail.aol.com/IM/?sn=madubois63&locale=en-us&pd=0) Love and kisses - Maryann

[Jackie07]

Good for you, Maryann. Let's not forget that those numbers are just statistics. I would think some of the patients benefit tremendously from Avastin, while some might not have. So, by not depriving patients right to get something that could be beneficial, FDA made a good decision. It's gonna be up to the patient and the doctor to decide whether or not to use the medicine.

[Lolly]

There are definitely two sides to this story; saftey and extending options for those of us for whom "progression-free" survival is not an abstract concept, but a reality. I'm currently on Avastin for skin metastisis, and Avastin + chemo has shrunk many lesions on my chest and stabilized others. I was holding my breath on this anticipated announcement, as my insurance would have definitely cut me off if the FDA ruled against approval. Yes, hopefully there are a few more options out there for me, Ixempra for one, but to me it is worth all the rare side effects to keep this particulary nasty type of metastisis under control.

<3 Lolly

[Mary Anne in TX]

I surely do want the option to say yes or no... not have the FDA make the decision for me. Give me all the horrible hard facts and let me decide along with my onc. ma