mTor inhibitor everolimus files 4 FDA approval er+ bc --also being tested vs her2+bc

[Lani]

everolimus is already approved for use in stents, renal cancer and pancreatic neuroendocrine tumors... it is close to approval for ER+ bc which has become resistant to anti-hormonals (and may someday be used to prevent er+ cancer becoming resistant to anti-hormonals)

here is today's news:

ZURICH—Novartis AG said Tuesday it will file its Afinitor drug for world-wide regulatory approval in breast cancer by year end on strong clinical-trial data, raising prospects the product will become a blockbuster and help the Swiss giant offset sales lost from drug-patent expirations.

Novartis said that a Phase III study showed Afinitor together with estrogen inhibitor exemestane "significantly" extended the time without tumor growth in women suffering from advanced breast cancer when compared with placebo plus exemestane.

The study, which involved more than 700 women, met its primary endpoint, Novartis said.

The Swiss company said it will present detailed data, including the drug's side effects, later this year at a medical conference.

"Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to [hormonal] therapy over time", said Herve Hoppenot, president of Novartis Oncology. "Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients."

Afinitor, which is already approved for other cancers in Europe and the U.S., works by inhibiting a protein that can trigger cancer growth.

Analysts expect the treatment, which last year saw its sales triple to $243 million, to become a blockbuster with more than $1 billion in annual sales if it wins approval in breast cancer.

Novartis is currently also investigating Afinitor—whose generic name is everolimus—in breast-cancer patients suffering from an overproduction of the so-called HER2+ protein, which controls cell growth.

Analysts said that while detailed data need to be studied, especially for potential side effects, chances that Afinitor may receive regulatory approval in the U.S. and Europe have increased, improving the likelihood that Novartis can balance expected sales losses from the patent expirations of medicines such as heart drug Diovan and cancer medicine Gleevec.

"Reaching the primary endpoint in the interims analysis is an encouraging signal," said Andrew Weiss, analyst at Bank Vontobel. "The breast-cancer indication is the most important for the Afinitor franchise," he said, adding that he believes there is a 40% probability that the drug will reach the market and generate peak sales of around $1.8 billion in this medical use.

Others foresee peak sales of around $1.5 billion, saying that Afinitor is one of several drugs that could reach blockbuster potential in the next few years.

[hutchibk]

http://www.medpagetoday.com/MeetingCoverage/ASCO/20504

I hope the FDA acts/feels more friendly towards Novartis than they have towards Genentech in the last year...

Sounds like this would be another good one to have in the tool box.

[Rich66]

I certainly like this..getting more out of seemingly under appreciated endocrine therapy. Also other available mTOR like metformin inhibs available now off label: http://her2support.org/vbulletin/showthread.php?t=41857

[Rich66]

wonder how close this is to being determined...

[Mandamoo]

I am on the Bolero 3 trial and think I am taking Everolimus (it's double blind so not sure) - I have been stable for 7 months. There is another woman at my centre who is NED and on Bolero 3 for 18 months now. The are also the Bolero 1 women and I know of one doing well - she is currently off herceptin due to low EF and just continuing on Everolimus and paclitaxil - I think they are quietly confident of good results in Her2 but don't have the numbers they need yet for the trial. It is a tolerable treatment once dosage are sorted out - ulcers being the main side effect of the Everolimus. I think it is good to see these options being trialled.
Amanda

[DeenaH]

Is there a link to this article? I can't find it via google and would like to include it in my appeal to my insurance company for this drug.

Thanks!

[Rich66]

Studies: New drug combinations slow down metastatic breast cancers
CNN International
By Miriam Falco, CNN Medical News (CNN) -- A new combination of treatments can help battle some forms of metastatic breast cancer and slow down the spread of the disease, according to two separate studies. The new studies show that the combinations of ...
See all stories on this topic »


Adding Afinitor to Herceptin May Provide Breast Cancer Benefit
http://ww5.komen.org/KomenNewsArticle.aspx?id=19327353167

Fellow Afinitor seekers:
http://www.inspire.com/groups/advanc...e=last#replies

[DeenaH]

I just got a letter from insurance today that the denial of Everolimus (Afinitor) has been overturned!! I am currently on Xeloda/Tykerb/Herceptin, but when that stops working, I now have approval to try Afinitor. I can't find any other person who is ER/PR- who has been approved for this drug outside of a trial. Hopefully this approval will help open the door for others. It took 2 1/2 months, and 2 appeals to get it through. It just shows that you should never take no for an answer. My UCSF doc didn't even feel comfortable writing a letter on my behalf because she thought the odds of it getting approved were non existent because I still have chemos I haven't tried. Thank goodness she was wrong!