Xtandi

Enzalutamide (XTANDI) Now Approved in Europe for Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic [...]

By Malecare|2017-10-19T10:47:41-04:00December 9th, 2014|Advanced Prostate Cancer, Drugs & Treatments, Enzalutamide (MDV-3100), European Union, General Information, Uncategorized, Xtandi|0 Comments

Europe Awaits Xtandi – A Positive CHMP Opinion on the Clearance of Enzalutamide In the Pre-Chemotherapy Stage of Prostate Cancer

Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure [...]

By Malecare|2014-10-24T09:52:48-04:00October 24th, 2014|Advanced Prostate Cancer, Chemo Therapy, Drugs & Treatments, enzalutamide, Uncategorized, Xtandi|0 Comments

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and [...]

By Malecare|2017-10-19T10:47:58-04:00September 30th, 2014|2nd line hormone therapy, abiraterone acetate, adjuvant therapy, ADT, Advanced Prostate Cancer, Alpha Emitting Radio Therapy, Alpharadin (radium-223), Androgan Receptor Inhibitor, Bio Chemical Recurrence, biomarkers, bisphosphonates, Bone Health, Bone Metastases, Bone Mineral Density, CAB, Cabazitaxel, Chemo Therapy, Chemo Therapy Failure, Clinical Trials, Clinical Trials, Combination Therapy, Cross Resistance, Cryotherapy, CTCs, denosumab - Xgeva, Diet, Diet and Supplements, Drugs & Treatments, Early Access Program (EAP), Early/Expanded Access Programs, End-Of-Life, enzalutamide, estrogen patches, FDA, Financial, Firmagon (degarelix), General Information, genetics, HIFU, Hormone Therapy, Hot Flashes, How We Live, immunotherapy, Incontinence, inflammation, ipilimumab, ketoconazole, Medicare/Medicaid, mental health, Metastases, MRIs, NCI, neuroendocrine prostate cancer, neutropenia, Nilandron, oligometastic, On The Horizon, Our Caretakers, Pain, perineural invasion, peripheral neuropathy, Personal Experiences, prognostic tools, Prostate Ponderings, Prostvac, Provenge, PSA, PSADT, Quality of Life, radiation proctitis, radiopharmaceuticals, Radiotherapy, Research, Revlimid (lenalidomide), salvage therapy, statins, supplements, survival, survivorship, TAK700, teleconferences, Uncategorized, Understanding APC, vaccines, Vitamine D3, weight gain, Xgeva, XL184, Xofigo, Xtandi, Zometa, Zytiga|1 Comment

Xtandi (enzaludamide) Receives FDA Approval in the Pre-Chemo Stage of Prostate Cancer Treatment

Expected and extraordinary news today on the new treatment front. Medivation and Astellas’ Xtandi (enzalutamide) was approved for use in men with castrate resistant prostate cancer. The new FDA approved label for Xtandi says that it is for the treatment of men with metastatic castration-resistant prostate cancer. This label is basically the same as for [...]

By Malecare|2014-09-10T17:03:53-04:00September 10th, 2014|abiraterone acetate, Advanced Prostate Cancer, Chemo Therapy, Drugs & Treatments, enzalutamide, General Information, survival, Uncategorized, Understanding APC, Xtandi, Zytiga|0 Comments

Clinical Benefit of Docetaxel or Enzalutamide After Progression on First-Line Abiraterone and Prednisone in Men with Metastatic Castration Resistant Prostate Cancer (mCRPC) *

Abiraterone acetate (AA) or Zytiga has demonstrated a survival benefit in the pre-chemotherapy setting for men with advanced prostate cancer that has become castrate resistant (mCRPC). As a result it is in widespread clinical use in the United States prior to the use of chemotherapy with docetaxel. Since its FDA approval post chemotherapy there has [...]

By Malecare|2017-10-19T10:48:05-04:00August 20th, 2014|abiraterone acetate, Advanced Prostate Cancer, Chemo Therapy, Cross Resistance, Drugs & Treatments, enzalutamide, Uncategorized, Understanding APC, Xtandi|0 Comments

British Men Who Have Had Abiraterone Will Not Get Enzalutamide Despite Its Life Extending Abilities

British Men Who Have Had Abiraterone Will Not Get Enzalutamide Despite Its Life Extending Ability Our brothers in England hit a major snag last week as NHS placed a burdensome restriction on the use of enzalutamide (Xtandi) for men with advanced prostate cancer who have already had abiraterone (Zytiga). Because of this ridiculous decision thousands [...]

By Malecare|2014-07-29T16:01:54-04:00July 29th, 2014|Advanced Prostate Cancer, Drugs & Treatments, enzalutamide, NICE, Uncategorized, United Kingdom - England, Northern Ireland, Scotland & Wales, Xtandi, Zytiga|0 Comments

Predicting Resistance to Enzalutamide and Abiraterone in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC).*

In yesterday's post I wrote about the possibility of looking for the presence of the splice variant ARV7 to determine if you would be resistant to enzalutamide (Xtandi). Today I am going to expand on this issue and discuss an additional study that demonstrated that the presence of ARV7 in circulating tumor cells not only [...]

By Malecare|2017-10-19T10:48:07-04:00July 16th, 2014|abiraterone acetate, Advanced Prostate Cancer, biomarkers, Drugs & Treatments, enzalutamide, General Information, ipilimumab, Research, Uncategorized, Understanding APC, Xtandi, Zytiga|0 Comments

Understanding and Predicting Initial Resistance to Enzalutimide (Xtandi) by Evaluating the Presence of ARV7 *

I have written a lot about how we need more data about the many new drugs we have to treat men with advanced prostate cancer. The many questions that continue to swirl around us pertain to the development of cross resistance (taking one drug causes another to not work) between these new drugs, knowing the [...]

By Malecare|2020-02-04T11:36:16-05:00July 15th, 2014|Advanced Prostate Cancer, Bone Metastases, Drugs & Treatments, enzalutamide, Uncategorized, Understanding APC, Xtandi|0 Comments

PSA Decline is a Potential Biomarker for Identifying Early Resistance to Zytiga and Xtandi In Men Who are Post Chemotherapy*

Abiraterone Acetate (Zytiga) and enzalutamide (Xtandi) are the newest generation hormonal agents. They both have demonstrated a survival advantage in men with castrate resistant prostate cancer (CRPC) who have already been treated with docetaxel (chemotherapy). Unfortunately all men who are responsive to both of these drugs eventually become resistant. Some men are subject to early [...]

By Malecare|2017-10-19T10:48:08-04:00July 9th, 2014|abiraterone acetate, Advanced Prostate Cancer, biomarkers, Drugs & Treatments, enzalutamide, General Information, Uncategorized, Understanding APC, Xtandi, Zytiga|0 Comments

Looking Forward Towards the Future – Zytiga or Xtandi First After Provenge

What will happen when enzalutamide (Xtandi) is approved for use in advanced prostate cancer in the disease stage prior to chemotherapy (that is if it is approved)? Already occupying this space and already approved by the FDA is both Provenge and abiraterone (Zytiga). Where will Xtandi fit in? Until we have a lot more data, [...]

By Malecare|2017-10-19T10:48:08-04:00June 27th, 2014|2nd line hormone therapy, abiraterone acetate, Advanced Prostate Cancer, Drugs & Treatments, enzalutamide, Provenge, Uncategorized, Understanding APC, Xtandi, Zytiga|8 Comments