Search: “Revlimid”

FDA extends review date for Celgene cancer drug

CHICAGO, Oct 3 (Reuters) – Celgene Corp. (CELG.O: Quote, Profile, Research) on Monday said U.S. regulators notified the company late Friday that the date for reviewing an application for its cancer drug Revlimid has been extended by three months, to Jan. 7.

Celgene said it expects to submit in November its application for Revlimid to treat previously treated patients with relapsed multiple myeloma.

Last week, Celgene said it expected a suspended trial of the drug to resume within weeks, after the trial design is changed to ensure all patients receive aspirin to reduce the chance of developing blood clots.

Trial

I don’t think I’m going to enroll in that trial. I wrote to Dr. Durie, and he suggested three treatment options for me.

  • Low dose Cytoxan with dex
  • Revlimid
  • Doxil and dex

You might know that Revlimid hasn’t been approved by the FDA for anyone to use yet, but I’ve been told there’s an extended access program that allows some patients to receive it. I’m going to call Celgene Monday to find out more. Also, I was told it should be commercially available in September/October.

Right now, I’m taking nothing. I dread seeing my next labs! Who knows though? Maybe not much will have happened.

My Labs

Sorry! I haven’t been very good about keeping up my labs. I’ll put relevant info into the main blog when I have it.



M-spike not high enough for trial

I had a test done to determine my m-spike to see if I could enroll in the Revimid (Revlimid) trial. It turned out my m-spike was 0.2 mg/dL. The study required an m-spike of 0.5 or higher. Mine was lower than it’s ever been in the history of my MM. I don’t qualify to be in the trial, but that’s not a bad thing. The research nurse said she hopes Revimid will be approved for use soon.

The results of the lab are posted online – choose “Home” from the menu on the right.

New Family Member

BuddyThere’s been a new addition to my family, and his name is Buddy. He’s a collie mix, with some really obvious collie features. I’m not sure what the other ingredients are. His head reminds me of the shape of a golden retriever or lab. I got him from the Collie Rescue of the Carolinas. He’s a very sweet dog of about 5 years of age. He’s stretched out on the floor now, after having investigated his new surroundings pretty thoroughly, including the back yard.

My back is aching from spending hours in the car today. That’s one of the things that’s really hard on me – driving or riding in the car. We went to Greensboro and picked up my nephew and then over to Winston-Salem to see Buddy. I kind of decided right on the spot that he was the dog for me. He’s such a nice boy! My poor cat is hiding out someplace now. I hope she adjusts quickly.

Tomorrow’s the start of another week. I have to have my INR tested tomorrow. I also have to fill my rx for Thalomid. Yes, that’s right. I’m on it for another month. I wanted to see about getting in a Revlimid trial. UNC isn’t participating in any. I think I want to look for a phase II trial though, because the phase III trial involves a placebo. I’m not sure I want to take that kind of chance! What if the MM advances while I’m just on monthly dex?

Drugs and discoveries

New discovery may lead to therapy for incurable blood cancer

A recent finding may lead to new treatments for multiple myeloma, an incurable cancer of immune cells called plasma cells that are present in the blood and bone marrow. The research, published in the February issue of Cancer Cell, reveals a frequent and common abnormal cellular event that occurs in about half of all myeloma cases and identifies an attractive target for therapeutic intervention. Read more here http://www.eurekalert.org/pub_releases/2004-02/cp-ndm021804.php

REVLIMID(TM) Receives Orphan Drug Designation From the European Commission For Multiple Myeloma

and…

Callisto Pharmaceuticals, Inc. (OTC BB: CLSP) announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the company’s lead drug candidate, Atiprimod, for the treatment of multiple myeloma, a blood cancer that proliferates in bone marrow. Callisto filed an investigational new drug application (IND) on Atiprimod in September 2003 and a Phase I/IIa clinical trial in multiple myeloma patients is expected to begin in January 2004.

Atiprimod has unique properties, centering on its ability to inhibit angiogenesis and proliferation of cancer cells through its ability to inhibit production of vascular endothelial growth factor (VEGF) and Interleukin-6 (IL-6), two essential factors for tumor growth and metastasis in multiple myeloma and other solid tumors. Patients will also be evaluated for the effect of Atiprimod on bone resorption, a debilitating side effect of multiple myeloma. Other anti-cancer uses for Atiprimod are presently being evaluated pre-clinically in
collaboration with the National Cancer Institute.

The FDA grants orphan drug status for drug candidates that are intended to treat rare life-threatening diseases that, at the time of application, affect no more than 200,000 patients in the United States. The drug must have the ability to provide significant patient benefit over currently available treatment or fill an unmet medical need. Orphan drug designation entitles Callisto to seven years of market exclusivity in the United States upon FDA approval, provided that Callisto continues to meet certain conditions established by the FDA.

Once the FDA grants marketing approval of a new drug, the FDA will not accept or approve other applications to market the same medicinal product for the same therapeutic indication. Other incentives provided by orphan status include certain tax benefits, eligibility for research grants and protocol assistance. Protocol assistance includes regulatory assistance and possible exemptions or reductions of certain regulatory fees.