4 months in those receiving bortezomib
plus dexamethasone (HR=0.
After the meeting, the company submitted additional information supporting Farydak s use for a different indication: patients with multiple myeloma who have received at least two prior standard therapies, including bortezomib
and an immunomodulatory agent.
MM-003 is a large, multi-centre phase 3 study that assessed the efficacy and safety of a new drug, Pomalidomide (POM) in combination with low-dose dexamethasone (POM+LoDex) and compared this combination with high dose dexamethasone in MM patients with late stage disease which have previously failed lenalidomide and bortezomib
They provide excellent pre-clinical rationale for expanding the use of ACY-1215 in combination with bortezomib
for patients with relapsed or refractory lymphoma.
in combination with bortezomib
and dexamethasone, as well as exploring the toxicities and the pharmacodynamics of the treatment combination, and determining the preliminary response rate in patients with relapsed or refractory multiple myeloma.
This dramatic change is mainly due to the introduction of novel agents such as the proteasome inhibitors bortezomib
and carfilzomib and the immune-modulatory drugs thalidomide, lenalidomide and pomalidomide.
Further, P5091 inhibits the growth of bortezomib
resistant multiple myeloma tumor cells and suppresses tumor burden in distinct animal tumor models.
Data presented at today's meeting included two clinical studies evaluating LBH589 in combination with bortezomib
and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma: a Phase III randomized, double-blind, placebo-controlled, multicenter global registration trial called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a Phase II US multicenter, single-arm, open-label study called PANORAMA-2
The CHMP positive opinion is based on a Phase 3 study comparing subcutaneous and intravenous administration of bortezomib
for relapsed myeloma patients.
We are very pleased to have shown that SNS01-T enhances the ability of bortezomib
to inhibit tumor growth in the mouse model and could be a way to lower the dose and reduce the severity of treatment-related side effects of bortezomib
," said Leslie J.
The application is based on data from the Phase 3 head-to-head ENDEAVOR study, which showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib
and low-dose dexamethasone (median progression-free survival[PFS] 18.
Contract notice: Tender for the Supply of Bortezomib