There is another difference. In a new trial "patient must be willing to practice two forms of contraception". In a previous one, only females should use "acceptable/effective method of contraception". Go figure.
Majority is needed for ODAC meeting to happen, not for FDA approval. It is what Raj said. Now let's think logically here. First, FDA wants this study to be conducted. Second, FDA thinks that early approval will kill enrollment process. What is your conclusion?
While the date of adcom meeting may depend on the number of patients enrolled, the final approval will require all patients to be in the study. According to Raj, FDA understands that after approval, it will be very difficult to enroll anyone. Who wants to be in placebo group when guaranteed treatment is already available?
on ClinicaltrialsDOTgov, NCT02563561.
Official Title: A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing TURBT
They want to enroll 1869 patients.
Found it in a RegenceRx policy.
I. Most contracts require prior authorization approval of belinostat prior to coverage. Belinostat may be considered medically necessary when criteria A, B and C below are met.
A. Documentation of a diagnosis of peripheral T-cell lymphoma (PTCL).
B. At least two prior therapies for PTCL were not effective (see Appendix 1 for therapy options).
C. There is a documented medical reason why romidepsin (Istodax) is not a treatment option.
I think “C” explains everything.
- Belinostat, an intravenously infused histone deacetylase (HDAC) inhibitor, is approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).
- Romidepsin (Istodax) is another intravenously infused HDAC inhibitor approved for relapsed or refractory PTCL. Among the infused HDAC inhibitors for PTCL, romidepsin (Istodax) provides the best value for Regence members.
Three studies were completed:
1. Maximum Tolerated Dose Study of Belinostat (PXD-101)in Combination With Paclitaxel Plus Carboplatin in Chemotherapy-Naive Patients With Stage IV Non-Small-Cell Lung Cancer (NSCLC), phase 1/2.
2. A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies, phase 1.
3. Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease, phase 1.
In both trials, primary completion date, August 2015, is Actual, not Anticipated. It means that Spectrum should already know the data on primary endpoints.
NSCLC trial NCT01741155:
Primary completion date moved from July 2015 to August 2015
Estimated Study Completion Date is same, December 2015
Biliary cancer trial NCT01773785:
Status changed from "recruiting" to "active, not recruiting"
"Did you get this info from ASCO"
No, you can find it in Talon's 10-Q from May 15, 2013.
Strange, I don't see your last two posts under the "Topics" view, only under the "Massages" view. Is this thread too old?
Marqibo's fate now is in hands of Germans. We need to wait until October 2016. If the results from phase 3 DLBCL study with elderly patients are positive, Marqibo will become a very important drug. Phase 2 data look good.
Since plasma clearance is slow, AUC for Marqibo is much higher relative to non-liposomal vincristine sulfate. In the study (ASH 2012) two doses were tested, 1.75 mg/m2 and 2.25 mg/m2, which are comparable to doses of vincristine. AEs were comparable. In conclusion, the authors stated "VSLI allows for intensification of vincristine therapy in children with cancer."
I think, she is going to present data from the phase1/2 trial "To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer", NCT01222780.
Marqibo is not only about dose capping. It is also about pharmacokinetics. At ASH 2012, Nirali Shah presented data from phase 1 pediatric study demonstrating that clearance of total vincristine in liposomal form (Marqibo) is approximately 100-fold lower in comparison to a standard vincristine.
at The Society for Adolescent and Young Adult Oncology (SAYAO) meeting, Oct 26 - Oct 28, 2015.
Session title: "Salvage Programs: What to offer in a crowded field of new options, what comes first?"
Talk title: "What about Marqibo? (Liposomal Vincristine)"
Presenter: Nirali Shah, MD · NCI Pediatric Branch
Yes, I think if they presented it right way, everybody could see that SPI-2012 and Neulasta are not much different. In my opinion, no difference is good. But Raj would not be able to brag about superiority.
"It states "6 mg as G-CSF" for Neulasta whereas 270 μg/kg “4 mg as G-CSF”. That's pretty clear."
No it is not. Look again at slide 6, presentation from Feb 2015.
Quote from the graph:
pegfilgrastim - 6mg (as G-CSF)
SPI-2012 - 135 μg/kg (2 mg as G-CSF)
Note what is written in parentheses. 2 mg is related to G-CSF but 6 mg is related to pegfilgrastim.
You cited that pegylation adds mass. Therefore, making pegfilgrastim you are adding mass to G-CSF, mass equal to G-CSF alone.
They did not show how much G-CSF is in 6 mg of pegfilgrastim. Misleading. 6mg of pegfilgrastim is a standard dose. According to my calculations, it is equal to 3 mg of G-CSF. And it makes a perfect sense. Look how gradually peak grows when you increase the dose of G-CSF from 2 mg to 3 mg (6 mg pegfilgrastim) and to 4 mg. It suggests bio equivalency of SPI-2012 and Neulasta.