HER2 Support Group Forums - View Single Post - mTor inhibitor everolimus files 4 FDA approval er+ bc --also being tested vs her2+bc

Lani · 07-06-2011, 06:56 AM

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.

07-06-2011, 06:56 AM	#1
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	mTor inhibitor everolimus files 4 FDA approval er+ bc --also being tested vs her2+bc 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.