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25 11, 2015

Financial aid: Takeda wants to help. Lets work together

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I had an opportunity to interview several Takeda Pharmaceutical team members about the company's new oral, proteasome inhibitor, Ninlaro (ixazomib), yesterday afternoon. I have heard from dozens of patients who find themselves stuck paying thousands of dollars out-of-pocket for two established oral chemotherapy drugs, Revlimid and Pomalyst. I'm concerned that the same obstacles might face

29 06, 2015

Myeloma News Update

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So much happened today--and it isn't over.  I'm heading to the BMT unit for yet another neupogen and Mozobil injection in a few moments. I'll post a medical update tomorrow morning.  In the meantime, there's been some myeloma related news.  The European Medicines Agency (EMA) is expected to approve panobinostat for use in Europe in

13 06, 2015

It’s official: panobinostat works!

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Novartis released final data from its PANORAMA Phase 3 panobinostat (Farydak) trial in advance of meetings (similar to ASCO or ASH) in Europe later this month: Novartis data at EHA show increased PFS benefit of Farydak® in new subgroup of patients with previously treated multiple myeloma - Panobinostat combination more than doubled median PFS benefit

23 02, 2015

Shocking about-face: FDA approves panobinostat

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In an unexpected move today, the FDA approved the new myeloma therapy, panobinostat. The approval is surprising, considering the FDA's own advisory committee had recommended denying Novartis' approval request as recently as November: Panobinostat gets a “thumbs down” in preliminary FDA hearing   FDA approval of panobinostat unlikely   Why the 180 degree turn-around?  I'll

2 12, 2014

Myeloma News: panobinostat, Kyprolis, oprozomib, Dr. Berenson Q/A

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Here we go!  Holiday is past and one week to ASH.  First, looks like Novartis managed to buy more time to try and save FDA ponobinostat approval: FDA extends review of panobinostat for combination treatment of mutliple myeloma By: ELIZABETH MECHCATIE, Oncology Practice Digital Network Dec 1, 2014  The Food and Drug Administration’s review of panobinostat,

7 11, 2014

FDA approval of panobinostat unlikely

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As I reported yesterday, an FDA committee has reviewed clinical trial results for the experimental myeloma drug, panobinostat.  Five of seven committee members voted not to recommend FDA approval. Apparently, the overriding concern was the number of patients that were forced to drop out of the Phase 3 PANORAMA1 clinical trial while using the drug. 

28 09, 2014

Which new myeloma drug will the FDA approve next?

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There are a half dozen experimental anti-myeloma drugs nearing the end of the research pipeline.  Which is most likely to be approved and when? A biologic immunotherapy drug like elotuzumab or daratumumab?  Millennium's new oral proteasome inhibitor, MLN9708? Although it only works well when combined with another drug like Revlimid, elotuzumab is the farthest along. 

9 06, 2014

Pat’s 2014 ASCO Review

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Disappointed with limited of myeloma related news trickling out of Chicago last week?  You shouldn't be. True, there wasn't a lot of new data presented at this year's American Society of Clinical Oncology (ASCO) meetings.  But some was significant.  And more will be available June 12th - 15th at the European Hematology Association (EHA) conference

16 01, 2014

Best of ASH (Part Four)

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During a presentation at our monthly Nature Coast Multiple Myeloma Support Group meeting last evening, oncologist Dr. Vikas Malhotra, reviewed the Multiple Myeloma Research Foundation's (MMRF) Best of ASH power point presentation.  Near the end, an experimental drug, indatuximab ravtansine, was listed as part of a short list of exciting new myeloma therapies.  No one

21 11, 2013

Staggering amount of myeloma related data to be revealed at this year’s ASH (Part Two)

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I promised more information about the upcoming American Society of Hematology (ASH) meetings in New Orleans; specifically data from promising clinical trials and laboratory studies that will be presented there.  Last week I ran these posts: Staggering amount of myeloma related data to be revealed at this year’s ASH (Part One)   Innovative genetic diagnostics

13 10, 2013

Panobinostat helps 50% of relapsed patients in new Dana-Farber study

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When I first started covering multiple myeloma news five years ago, an experimental drug, panobinostat, was one of the first to catch my eye.  But after a hot start, "pan" was overshadowed by carfilzomib (Kyprolis) and pomalidomide (Pomalyst) and seemingly disappeared.  I'm pleased to report that panobinostat may be making a comeback. In an article