To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
Showing posts with label mdv-3100. Show all posts
Showing posts with label mdv-3100. Show all posts
Sep 14, 2012
KOIN TV visits about a new drug for prostate cancer
As part of their Stand Up to Cancer programming, KOIN-TV visited with us a bit ago. This in an inspiring piece with one of our cancer patients. We are so glad to see stories like this become a reality.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
Aug 31, 2012
Enzalutamide approved - clinical trials deliver
Enzalutamide (formerly MDV-3100) is a drug for advanced prostate cancer that we have mentioned a number of times. Today, it is no longer experimental. It is approved and very soon patients with advanced prostate cancer will have another option for treatment. This is what clinical trials are all about.
The following is a message from the FDA's Office of Hematology and Oncology Products Director, Dr. Richard Pazdur.
On August 31, 2012, the U. S. Food and Drug Administration approved enzalutamide (XTANDI® Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
The approval was based on a single randomized, placebo-controlled, multicenter trial enrolling 1199 patients with metastatic castration-resistant prostate cancer who had received prior docetaxel. Patients were randomly allocated to receive enzalutamide 160 mg orally once daily (N = 800) or placebo (N = 399). Study treatment continued until disease progression, initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal. Patients were required to continue androgen deprivation therapy and were allowed, but not required, to continue or initiate glucocorticoids during the study period. Forty-eight percent (48%) of patients on enzalutamide and 46% on placebo received glucocorticoids.
The primary efficacy endpoint was overall survival (OS). At the pre-specified interim analysis after 520 events, a statistically significant improvement in OS [HR 0.63 (95% CI: 0.53, 0.75), p < 0.0001, log rank test] was observed. The median OS was 18.4 and 13.6 months in the enzalutamide and placebo arms, respectively.
The most common (>=5%) grade 1-4 adverse reactions included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 3-4 adverse reactions were reported in 47% of patients treated with enzalutamide and in 53% of those on placebo.
Seizures occurred in 0.9% of patients on enzalutamide. No patients on the placebo arm experienced seizures. In the clinical trial, patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizures were excluded from the clinical trial. The safety of enzalutamide in patients with predisposing factors for seizures is unknown.
The recommended dose and schedule for enzalutamide is 160 mg orally once daily.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
The following is a message from the FDA's Office of Hematology and Oncology Products Director, Dr. Richard Pazdur.
On August 31, 2012, the U. S. Food and Drug Administration approved enzalutamide (XTANDI® Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
The approval was based on a single randomized, placebo-controlled, multicenter trial enrolling 1199 patients with metastatic castration-resistant prostate cancer who had received prior docetaxel. Patients were randomly allocated to receive enzalutamide 160 mg orally once daily (N = 800) or placebo (N = 399). Study treatment continued until disease progression, initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal. Patients were required to continue androgen deprivation therapy and were allowed, but not required, to continue or initiate glucocorticoids during the study period. Forty-eight percent (48%) of patients on enzalutamide and 46% on placebo received glucocorticoids.
The primary efficacy endpoint was overall survival (OS). At the pre-specified interim analysis after 520 events, a statistically significant improvement in OS [HR 0.63 (95% CI: 0.53, 0.75), p < 0.0001, log rank test] was observed. The median OS was 18.4 and 13.6 months in the enzalutamide and placebo arms, respectively.
The most common (>=5%) grade 1-4 adverse reactions included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 3-4 adverse reactions were reported in 47% of patients treated with enzalutamide and in 53% of those on placebo.
Seizures occurred in 0.9% of patients on enzalutamide. No patients on the placebo arm experienced seizures. In the clinical trial, patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizures were excluded from the clinical trial. The safety of enzalutamide in patients with predisposing factors for seizures is unknown.
The recommended dose and schedule for enzalutamide is 160 mg orally once daily.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
Aug 13, 2012
Video: abiraterone and enzalutamide for advanced prostate cancer: results from ASCO 2012 discussed
A video summary of the most important data regarding abiraterone (Zytiga ®) and enzalutamide (MDV-3100) - two of the most important new drugs in prostate cancer. Recorded at ASCO 2012.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
May 9, 2012
Video: Latest Developments in Advanced Prostate Cancer Treatment with Dr. Beer
A comprehensive discussion on all the principal current treatments and the most promising emerging drugs for advanced prostate cancer. In this talk, we discuss hormonal agents including abiraterone and MDV-3100, chemotherapy drugs including docetaxel and cabazitaxel, immunologic therapy with sipuleucel-T, biologic therapy with XL-184, and bone targeted therapy with alpharadin. We then put it altogether to offer a vision for the treatment paradigm of the near future.
For those of you that watched the previously posted talk, this one is a bit more inclusive and comprehensive. It is a different program that was put together with the team at Medscape.
To see the entire program and slides, you will need to go the Medscape website. You will likely need to sign up to be a member of Medscape to get full access to these materials. There is no cost to doing this.
To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon.
(c) 2012 Tom Beer and Larry Axmaker
For those of you that watched the previously posted talk, this one is a bit more inclusive and comprehensive. It is a different program that was put together with the team at Medscape.
To see the entire program and slides, you will need to go the Medscape website. You will likely need to sign up to be a member of Medscape to get full access to these materials. There is no cost to doing this.
To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon.
(c) 2012 Tom Beer and Larry Axmaker
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