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FDA

Home/Tag:FDA
24 01, 2016

FDA expands access to Kyprolis. Big news?

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Friday the FDA expanded it's approval of how and when carfilzomib (Kyprolis) can be used. Trumpets sounded. I counted eleven industry news outlets that led with the story. My reaction? Big yawn. I wasn't even going to post about it. But Saturday a half dozen more publications ran stories about it, so I felt we

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

27 08, 2015

BREAKING NEWS: Daratumumab pushes forward toward FDA approval

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Important news as the promising new immunotherapy, daratumumab, continues to move swiftly toward FDA approval. My friends at Genmab and Jannsen in the Netherlands emailed me details last evening, along with some helpful background information to review: Daratumumab is an investigational human anti-CD38 monoclonal antibody that received Breakthrough Therapy Designation from the FDA in May,

10 06, 2015

Baseball great Mel Stottlemyre facing relapse

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Before I pass along information about Mel Stottlemyre, I wanted to follow-up on my post about daratumumab from yesterday; the companies involved have officially applied for FDA approval. I noticed the Myeloma Beacon ran a story about it; glad they're still relevant and on top of breaking news.  But for a slightly different business slant,

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

22 02, 2015

Running out of treatment options? FDA may be able to help

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The FDA is considering a radical new, streamlined approach to granting access to experimental drugs.  For those of us that desperately need more myeloma treatment options, I can't imagine better news. Read this excerpt from the opinion pages in last week's New York Times: The Food and Drug Administration has proposed a greatly simplified process

19 02, 2015

BREAKING NEWS: Revlimid receives expanded FDA approval

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I received some good news from Eliza Schleifstein with Cegene.  She passed along this information for me to share: Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID® (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. The treatment is

13 02, 2015

BREAKING NEWS: A tale of two promising myeloma therapies

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I'm delaying a follow up post I've been working on, Reaching patients in need can be challenging, to bring you some important news concerning two important new drugs--ixazumib and SAR650984--and the companies that make them. Ixazomib first.  An oral proteasome inhibitor, ixazomib (MLN9708) was developed by Millinnium Pharmaceuticals in Cambridge, Massachusetts.  Early clinical trial results

30 12, 2014

Who knew? HIV and diabetes drugs cause myeloma cells to self destruct

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Sometimes medicines created to fix one thing end up working for something else, too.  I'm fascinated by the prospects that existing drugs--most likely used in unexpected combinations--may work against multiple myeloma, help us live longer.   Here's an example. Apparently the HIV drug, ritonavir, and diabetes drug, metformin, are toxic to myeloma cells.  Will the accidental

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.