No, Istodax has the same mechanism of action as Belinostat. There is no reason to use Belinostat after Istodax or Istodax after Belinostat, since they both hit the same target. Istodax and Belinostat are direct competitors. Therefore, I was surprised to see that Istodax has a competitive advantage in terms of pricing. I thought that Spectrum will price Belinostat a bit lower.
According to Zacks
1. Product sales from Zevalin in Hong Kong will be generated in 2015
2. Approval of Zevalin in China in 2019
3. Approval of Marqibo and Evomela in China in 2020
"after all the other drugs on the list have failed"
There is no evidence that Belinostat works after Istodax failure. Patients treated with Istodax were excluded from Belinostat study.
Sure, you can read it in the article "Belinostat (Beleodaq) for Peripheral T-Cell Lymphoma" published in The Medical Letter (2015), Vol 57, e66-e67.
To estimate cost, they used a dosage 1000 mg/m2 IV over 30 mins on days 1-5 of a 21-day cycle. They did not mention cost for each cycle. However you can find it elsewhere. For example, according to Fallon Health Pharmacy, it is $36,000 per cycle. In six months, you have approx. 9 cycles. Do the math.
BTW, median duration of response for Beleodaq in R/R PTCL is 8.4 months.
Approximate wholesale acquisition cost (WAC) for about 6 months’ treatment for a 1.7 m2 patient. Source: AnalySource® Monthly. April 5, 2015.
Did not expect that Beleodaq is most expensive. How it is going to compete with Istodax?
and like big pictures, tell us about your vision. Tell us how you like Raj's leadership, company performance, goals accomplished, deserved bonuses etc. Do not hesitate. Fulfill your dream.
You know what I mean. This trial (enrollment) was stared almost 9 years ago and 7 years ago enrollment was completed. I do not pretend anything. "This trial does not matter" if you are not curious enough. I found it interesting and posted it here. And what I posted is true. Have a problem with that?
No, I really follow Spectrum's drugs in development. I found inconsistency and asked a question. Your answer is wrong as always. It is not "based on date first received". "First received" was nine years ago. And do not advise me what should I focus on. It is none of your business. Especially when you don't understand what is important and what is not.
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease, NCT00364676 (phase 1)
Primary completion date moved from Dec 2014 to Jun 2015. Wonder why it was not terminated.
I am not an expert and therefore recommend you to read an article “Marker Lesion Experiments in Bladder Cancer—What Have We Learned?” J. Urol. 2010, 1678-1685
1. “According to phrase 18 of the World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, the 2 components that must be present in every experiment using human subjects are safety and an opportunity to benefit from participation in the study. Accordingly many institutional review board committees find it difficult to approve studies in which a malignant tumor is deliberately left unresected.”
2. It seems like ML approach in urology has been used only for phase 1/2 studies and mostly (only) in Europe.
3. Very few patients could be qualified for ML studies and I am not sure they will agree to have tumors not removed from their bladders.
4. ML is an informative type of study if you want to know response rates, actually only CRs, but not time for tumor recurrence. It is my opinion.