F.D.A. Revokes Approval of Avastin as Breast Cancer Drug

[cal04]

Source: NY Times

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

The commissioner, Dr. Margaret A. Hamburg, said that the drug was not helping breast cancer patients to live longer or control their tumors, but did expose them to potentially serious side effects such as severe high blood pressure and hemorrhaging.

“This was a difficult decision,” Dr. Hamburg, said in a statement. The F.D.A. “recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use.

“After reviewing the available studies,” she continued, “it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will help them live longer or improve their quality of life.”

Read more: http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html

[sharp_stick]

1. That's a shame

there was so much hope with that drug.

[CountAllVotes]

2. Avastin is a very valuable drug

My husband has been receiving injections into the one eye he can still see out of with Avastin about every 6-8 weeks since June of 2008 (condition was exacerbated by a severe case of the shingles :( ). He will require this treatment for the rest of his life, it is not a complete cure and only works well on some people, not everyone with wet macular degeneration.

This drug is injected into the eyeballs of many out there that suffer from wet macular degeneration.

My husband went from being blind to his eye sight recovering to 20/35 which is good enough to drive with. :)

Just because Avastin (which shrinks masses) isn't helpful for breast cancer does not mean it is not extremely valuable for wet AMD.

:dem: :kick: & recommend (for Avastin).

[Wilmer]

4. Avastin is a very valuable drug

I've been receiving Avastin injections in one eye, to help deal with the side effects of radiation treatments (for eye cancer). The vision in that eye ceased to deteriorate, probably as a consequence.

I would hope that everyone else who needs this valuable drug might have access to it.

[CountAllVotes]

5. wow, well I'm glad you are improving!

I never thought of Avastin to be used for eye cancer/radiation treatments, but it sure makes a lot of sense!

Welcome to the Democratic Underground and I hope you find a lot of good help/info. here. :D

:kick:

[gratuitous]

3. Gummint regulation!

If women want to buy false hope and expose themselves to heightened health risks, shouldn't that be their choice, and none of the gummint's bidness? Oh, and we need tort reform so that pharmaceutical manufacturers can't be sued if their product kills someone.

[SoapBox]

6. For macular...isn't it still off label use?

My Mom has had macular treatments for years...I can never remember which drug is which. There is ONE that was actually approved for use and then one that was off label...isn't the off label the Avastin?

Hell, I'm not even sure which one her specialist is now using...they have flipped back and forth over the years.

[CountAllVotes]

7. it is off label for macular degeneration

The one that has been extensively used is called "Lucentis" and it costs 100X the amount of Avastin. Needless to say, they are pushing Avastin and the results seem to be similar best I know.

[Sgent]

9. Close

Avastin was created and used in eyes before Lucentis existed. When the drug company found out Avastin was effective in the eye, they created a slightly modified version (chemically almost identical), called it Lucentis, put it in single dose vials and charged 100X more per dose.

They COULD have just but Avastin itself in a single dose vial, but then they would only get 20-30 / dose instead of $2000+.

Lucentis exists for one reason -- the marketing department.

[BlueIris]

8. Two steps foward...nt