Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

In continuation of my update on abiraterone acetate

Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration (FDA) for Yonsa (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO - North America, Sun Pharma.

Yonsa in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.

Abiraterone: Hint of considerable added benefit for patients with metastatic prostate cancer

In continuation of  my update on Abiraterone

Abiraterone acetate (abiraterone for short, trade name: Zytiga) has been approved in Germany since December 2012 for men with metastatic prostate cancer that is not responsive to hormone blockade, who only have mild symptoms or so far none at all, and in whom chemotherapy is not yet indicated. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy....

Abiraterone: Hint of considerable added benefit for patients with metastatic prostate cancer

Abiraterone improves outcomes for prostate cancer prior to chemo

In continuation of my update on abiraterone

Abiraterone improves outcomes for prostate cancer prior to chemo

Golden age of prostate cancer treatment hailed as fourth drug in two years extends life

We know that, Enzalutamide (formerly known as MDV3100, see the structure) is an experimental androgen receptor antagonist drug developed by the pharmaceutical company Medication for the treatment of castration-resistant prostate cancer currently in phase 3 clinical trials. Results so far have been encouraging; Medivation has reported up to an 89% decrease in prostate specific antigen serum levels after a month of taking the medicine. Early preclinical studies also suggest that enzalutamide inhibits breast cancer cell growth. 

Researchers from Institute of Cancer Research, London, and its partner hospital The Royal Marsden NHS Foundation Trust jointly led the new Phase III trial of enzalutamide and the Phase III trials of two other drugs, cabazitaxel and abiraterone. Abiraterone was also discovered at The Institute of Cancer Research and was recently made available on the NHS. A further drug sipuleucel-T has also been shown to extend life in the two-year period.

"What we're seeing now is an unprecedented period of success for prostate cancer research, with four new drugs shown to extend life in major clinical trials in just two years, and several others showing promise. It truly is a golden age for prostate cancer drug discovery and development" claims Prof. Martin Gore....

Golden age of prostate cancer treatment hailed as fourth drug in two years extends life

For advanced prostate cancer, new drug slows disease

In continuation of my update on abiraterone

The study is the first randomized clinical trial to document expanded benefits among a particular group of prostate cancer patients in whom the disease had spread. The medication, abiraterone acetate -- marketed as Zytiga -- also delayed the development of pain and deterioration of the patients' overall condition.

The researchers say the medication could provide new treatment options.

"This drug extended lives and gave patients more time when they weren't experiencing significant pain from the disease,'' said the principal.....

For advanced prostate cancer, new drug slows disease

Advanced Prostate Cancer Drug May Help at Earlier Stage

In continuation of my update on abiraterone

Advanced Prostate Cancer Drug May Help at Earlier Stage:  A drug approved to treat advanced prostate cancer appears to help men who have localized high-risk prostate cancer if given before surgery. Adding Zytiga (abiraterone) to conventional hormonal treatments eliminated or nearly...

Abiraterone acetate can help eliminate prostate tumors

In continuation of my update Abiraterone

Abiraterone acetate can help eliminate prostate tumors: A hormone-depleting drug approved last year for the treatment of metastatic prostate cancer can help eliminate or nearly eliminate tumors in many patients with aggressive cancers that have yet to spread beyond the prostate, according to a clinical study to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), June 1-5, in Chicago.

FDA approves new targeted therapy to treat men with advanced prostate cancer..

In continuation of my update on  Abiraterone ....

We know that, Abiraterone (tradename Zytiga) is a drug currently under investigation for use in castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) (prostate cancer not responding to androgen deprivation or treatment with antiandrogens). 

It blocks the formation of testosterone by inhibiting CYP17A1 (CYP450c17), an enzyme also known as 17α-hydroxylase/17,20 lyase. This enzyme is involved in the formation of DHEA and androstenedione, which may ultimately be metabolized into testosterone.This drug was initially discovered at the Institute of Cancer Research in London. 

Recently  approved abiraterone. It improves, by nearly four months, the overall survival rate of men with metastatic chemotherapy- and castration-resistant prostate cancer. Since 2005, the Prostate Cancer Foundation invested $8.2 million in over six research projects to advance independent academic research for investigating abiraterone's mechanism of action and biomarkers to predict patient response...

More....

Positive phase II clinical results of abiraterone (for advanced prostate cancer)....

We know that,  Abiraterone (discovered and developed at the Institute of Cancer Research in London, see structure) is a drug under investigation for use in hormone-refractory prostate cancer (prostate cancer not responding to treatment with antiandrogens). Abiraterone acts  by blocking the formation of testosterone by inhibiting CYP17A1 (CYP450c17), an enzyme also known as 17α-hydroxylase/17,20 lyase.  This enzyme is involved in the formation of DHEA and androstenedione, which may ultimately be metabolized into testosterone.

 

The latest trial, which was led by the ICR and the Royal Marsden  NHS Foundation Trust, is the first to investigate the drug in men with such advanced prostate cancer.

A total of 47 men were recruited for the trial, all of whom had late-stage castration-resistant prostate cancer, which means that their disease was advanced and their tumors were no longer responsive to androgen deprivation therapy. In almost all cases, the men's cancer had spread to their bones. All of the participants had already received hormone therapy and the chemotherapy drug docetaxel, but were no longer responding to those treatments. By the end of the study period, researchers found that around three-quarters of men had experienced a drop in levels of prostate specific antigen (PSA), which is often raised in men with prostate cancer and can be used to measure disease activity.

 In around half of the men,  PSA levels fell by at least 50 per cent, while three-quarters of participants also had a drop in the number of tumor cells circulating in their blood. Three years after the start of the trial, five of the patients were still taking abiraterone and benefitting from the treatment. Lead researcher Dr Alison Reid, also from the ICR and the Royal Marsden, noted that "abiraterone shrank or stabilised men's cancers for an average of almost six months, which is a very impressive result with only mild side-effects". 

Though the initial results are exciting, the researchers conclude that there's a lot more work needed to establish what abiraterone's place will be in treating men with prostate cancer....

Ref :http://info.cancerresearchuk.org/news/archive/cancernews/2010-02-16-New-drug-shows-promise-for-advanced-prostate-cancer-patients