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So, What’s Up With Revlimid?
By The Unknown Patient
05.16.05

The Unknown Patient Reports From Orlando

The Unknown Patient has been asked by many of his fellow myeloma fighters about when Revlimid (also known as Lenolidomide and CC-5013) will become available.  Revlimid has been in the news recently because of successes in clinical trials for myeloma.  It is said to work very well and have many fewer side effects than thalidomide.  Revlimid could potentially offer options for people for whom other drugs, including thalidomide, have stopped working.  It could also be an alternative for people who can’t tolerate the side effects of their current therapies.

Revlimid is a "thalidomide analog," meaning that its chemical formulation is based on thalidomide, but intended to remove the parts of the thalidomide molecule that cause that drug's most serious side effects (e.g., birth defects, neuropathy, and constipation) while retaining the parts that make it effective against myeloma. 

Exciting results of randomized clinical trials of Revlimid conducted in the US and in Europe/Israel were presented at the 10th International Myeloma Workshop in Sydney, Australia and updated at the annual meeting of the American Society of Clinical Oncology this past weekend in Orlando.  These trials were stopped because the results were conclusive that new therapy being tested (Revlimid plus dexamethasone) delivered better results than the control arm (dexamethasone alone.)  These results will form the basis for submission of an NDA (new drug application) to the FDA (Food and Drug Administration) to seek approval of Revlimid for use in myeloma.

However, for those of you thinking that this sounds like Revlimid won’t be available for a long time, think again.  There are a number of ways Revlimid could soon be available to those who need it.

First, the Unknown Patient spoke with a number of senior people from Celgene in Sydney and then in Orlando .  They assured him that there is an "Expanded Access Program"  (EAP) being put in place.    The EAP protocol has been submitted to the FDA and has a 30 day turnaround time. Looking at what needs to happen if/when the FDA notifies Celegene about proceeding with the program, Celgene expects it will likely make Revlimid available on a limited basis via the EAP as early as mid-July. An EAP is a mechanism for making unapproved drugs with clear benefit available to patients who have a specific need before approval.  EAP programs benefit patients by providing early access to drugs that have been shown to be safe and effective in clincical trials while the FDA is reviewing their application for approval.  They are also used to gather more data on drug safety before the drug is introduced broadly into the market.  Important details about this program (eligibility criteria, size of the program, firm roll out dates) remain Unknown but more information should be available soon.

Second, and more importantly, Celgene has already submitted its NDA to the FDA for use of Revlimid for treating Myelodysplastic Syndrome (MDS.)    Revlimid had very positive results in trials for MDS and it seems to be headed for approval sometime late this year for treating this condition.  In fact, there was more positive data on Revlimid for MDS presented at ASCO this past weekend.  If Revlimid is approved for treating MDS, physicians then legally prescribed it for use in the US in myeloma.  This is called "off label usage."  

In reality, all use of thalidomide in the US today is "off label" as thalidomide has only been approved for treatment of leprosy.  It has never been approved for myeloma.  The application for thalidomide approval is currently being reviewed by the FDA.   This past October, the FDA sent Celgene an “approvable letter” saying that the drug could be approved for myeloma if further data from a trial completed by the Eastern Cooperative Oncology Group were submitted to the FDA for review.   The timing of this submission or the decision on thalidomide is unclear at this point.

So, it could be that Revlimid will follow a similar path of "off label" usage if it is approved for MDS.  The difference is that Revlimid could be approved for myeloma within the year following the potential MDS approval date.

Bottom line, we can be hopeful that Revlimid will become available to myeloma patients on a limited basis this summer as part of an EAP, with broad availability sometime later this year if it is approved for MDS.

The Unknown Patient is sorry he had to use all that Unknown mumbo-jumbo to explain what's up with Revlimid.  He hopes this report was understandable and helpful.


 related articles
Randomized Phase III Study Comparing Conventional-Dose Treatment Using a Combination of Lenalidomide (Revlimid®), Bortezomib (Velcade®), and Dexamethasone (RVD) to High-Dose Treatment with Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age
Revlimid Webcasts from American Society of Hematology (ASH) Meeting 2011
Open REVLIMID® (Lenalidomide) Clinical Trials
Eastern Cooperative Oncology Group Clinical Trial:E1A05
Fast Track for First Prescription™
Celgene's Patient Support Coordinator Program
REVLIMID®/THALOMID® TIP CARD
Understanding Revlimid®
CITINGS
Revlimid Prescribing Information, including updated renal dosing guidelines
Celgene Pharmaceuticals
From the Archives:
Life-Changing Benefits of Revlimid® Recognized by the Prix Galien USA Award 2008
REVLIMID® Meets Important Quality of Life Measures
REVLIMID® EXTENDS SURVIVAL WITH POSITIVE IMPLICATIONS FOR A WIDE RANGE OF BLOOD CANCERS
Drug Compendia List Revlimid for Frontline Treatment of Myeloma
IMF REPORTS POSITIVE SHIFT IN TREATMENT PARADIGM FOR PATIENTS
THE INTERNATIONAL MYELOMA FOUNDATION SAYS CELGENE LAUNCHES NEW "PATIENT SUPPORT COORDINATOR" PROGRAM AT MEETING OF SUPPORT GROUP LEADERS IN PHOENIX
THE INTERNATIONAL MYELOMA FOUNDATION SAYS CLINICAL TRIAL RESULTS COULD IMPROVE SURVIVAL WHILE REDUCING SIDE EFFECTS FOR MANY PATIENTS
IMF Says Revlimid Approval Could Benefit Patients Throughout Europe
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REVLIMID® APPROVAL FOR MYELOMA CAN BE LIFE-CHANGING FOR CANCER PATIENTS
Blood Cancer Breakthroughs Presented at ASCO 2006
Revlimid® Accepted by EMEA for Evaluation as Oral Therapy for Relapsed or Refractory MM
FDA Grants 'Priority Review' for Revlimid
Revlimid Update: Where Do We Stand?
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IMF LOOKS FORWARD TO RAPID REVIEW OF REVLIMID FOR MYELOMA PATIENTS FOLLOWING FDA APPROVAL FOR MDS
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You might also be interested in:

Clinical Trials
Randomized Phase III Study Comparing Conventional-Dose Treatment Using a Combination of Lenalidomide (Revlimid®), Bortezomib (Velcade®), and Dexamethasone (RVD) to High-Dose Treatment with Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

This study, sponsored by Dr. Paul Richardson of the Dana-Farber Cancer Institute, was designed to answer a very important question in myeloma: In the era of novel drugs, is high-dose therapy (HDT) still necessary in the initial management of multiple myeloma in younger patients? In this study, the addition of HDT to conventional dose treatment (RVD) as compared to conventional-dose treatment (RVD) alone would be considered superior if it significantly prolongs progression-free survival by at least 9 months.


Revlimid Webcasts from American Society of Hematology (ASH) Meeting 2011

Open REVLIMID® (Lenalidomide) Clinical Trials
From the National Cancer Institute's cancertrials.gov, a list of the Revlimid trials that are currently recruiting patients.

Eastern Cooperative Oncology Group Clinical Trial:E1A05
Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) & Lenalidomide (Revlimid®) - Dexamethasone (VRD) versus Bortezomib (Velcade®:) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen

Patient Assistance
Fast Track for First Prescription™
Celgene has developed a new program called Fast Track for First Prescription™ to help eligible patients receive their first prescriptions for a Celgene product quickly and efficiently.

Celgene's Patient Support Coordinator Program
Celgene's Patient Support Coordinators assist patients and healthcare providers to navigate the challenges of reimbursement, provide information about co-pay assistance, and answer general questions about Revlimid.

General Information
REVLIMID®/THALOMID® TIP CARD
This handy tip card includes indications, dosage, and potential side effects.

Understanding Revlimid®
Revlimid® is an immunomodulatory agent. It is a drug that can modify or regulate the functioning of the immune system. These agents appear to have multiple actions, including both anticancer and anti-inflammatory activities.

CITINGS
A quarterly publication featuring the most up-to-date information on research advances and new therapies for the treatment for multiple myeloma. CITINGS provides physicians and other health care professionals with references and Internet links to the most current U.S. and international journal articles, abstracts, and white papers. Several issues have been published on Revlimid™.

Revlimid Prescribing Information, including updated renal dosing guidelines

Celgene Pharmaceuticals
Click here to view their most recent press releases.

From the Archives:
BLOOD Reports Revimid™ Has Anti-Tumor Activity in Patients with Relapsed and Refractory Multiple Mye

News
Life-Changing Benefits of Revlimid® Recognized by the Prix Galien USA Award 2008
The Prix Galien Award recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines.

REVLIMID® Meets Important Quality of Life Measures
Research presented at the British Society for Haematology Annual Meeting demonstrates that REVLIMID® has the ability to add years to myeloma patients’ lives, and that these years fall within the quality-adjusted life years, or QALY guidelines. QALY is a measurement of cost-effectiveness of a drug based on quality of life achieved, not just the number of years.

REVLIMID® EXTENDS SURVIVAL WITH POSITIVE IMPLICATIONS FOR A WIDE RANGE OF BLOOD CANCERS
Two Studies in the Prestigious New England Journal of Medicine Validate the Findings.

Drug Compendia List Revlimid for Frontline Treatment of Myeloma
Such a listing not only sets the groundwork for Medicare reimbursement of frontline Revlimid, but may ease the process of reimbursement from other insurers as well.

IMF REPORTS POSITIVE SHIFT IN TREATMENT PARADIGM FOR PATIENTS
Second Closure of Multi-Center Trial in 4 Weeks Reinforces Benefits of Using REVLIMID® with Low Dose Steroids in Myeloma

THE INTERNATIONAL MYELOMA FOUNDATION SAYS CELGENE LAUNCHES NEW "PATIENT SUPPORT COORDINATOR" PROGRAM AT MEETING OF SUPPORT GROUP LEADERS IN PHOENIX
New Program Developed Following Meetings to Address Patient Questions and Concerns

THE INTERNATIONAL MYELOMA FOUNDATION SAYS CLINICAL TRIAL RESULTS COULD IMPROVE SURVIVAL WHILE REDUCING SIDE EFFECTS FOR MANY PATIENTS
Findings Show Survival Improvement with Lower Doses of Dexamethasone, the Steroid Commonly Used with REVLIMID® and other Drugs in Newly Diagnosed Myeloma

IMF Says Revlimid Approval Could Benefit Patients Throughout Europe
Patients, Advocates and Experts Applaud Positive Opinion from EU Advisory Committee

IMF Addresses the High Cost of Cancer Therapies
We are pleased that REVLIMID has been approved, but we are concerned about the high cost of cancer therapies in the current reimbursement environment. On the International Myeloma Foundation hotline we hear daily from myeloma patients who are forced to choose medical alternatives when costs are too high and reimbursement too low. We will look into reimbursement for Revlimid and coverage under the various Medicare plans and help our patients through the system. As patient advocates we will work with Celgene, with other pharmaceutical companies, and the government to help ensure that therapies are available to all who need them and are not out of reach because of price or reimbursement.

REVLIMID® APPROVAL FOR MYELOMA CAN BE LIFE-CHANGING FOR CANCER PATIENTS
The International Myeloma Foundation – supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said FDA approval of REVLIMID® (lenalidomide) for patients with myeloma is a major new addition to the group of treatments that together have the potential to significantly extend patients' lives.

Blood Cancer Breakthroughs Presented at ASCO 2006
Breakthroughs in the treatment of blood cancer were presented at the American Society of Clinical Oncology (ASCO) meeting in Atlanta. In one of the findings, Revlimid® was shown to extend life for patients taking the drug. This is a major advancement as the majority of multiple myeloma can now consider multiple myeloma a chronic, manageable condition. Video featuring patients Hardy Jones and Paul Nicholss and the IMF's Dr. Brian Durie.

Revlimid® Accepted by EMEA for Evaluation as Oral Therapy for Relapsed or Refractory MM
The International Myeloma Foundation is pleased to report another important step toward approval of Revlimid for multiple myeloma, this time in Europe.

FDA Grants 'Priority Review' for Revlimid
The FDA has granted a "priority review" for Revlimid in combination with dexamethasone for myeloma patients who have been treated with at least one previous regimen.

Revlimid Update: Where Do We Stand?
Revlimid® (Lenalidomide) is an important new agent for the treatment of myeloma. It has shown great promise as both a single agent and in combination with dexamethasone and other drugs. With use of Revlimid there is much less risk of nerve toxicity than with thalidomide, which is one of the reasons patients have been eagerly awaiting access to it.

FDA Approves Celgene's Revlimid For Treatment Of MDS
Revlimid from the Celgene Corporation was just approved by the Food and Drug Administration to treat certain patients with a malignant blood condition called myelodysplastic syndrom (MDS.) The IMF looks forward to rapid review of Revlimid for Multiple Myeloma.

IMF LOOKS FORWARD TO RAPID REVIEW OF REVLIMID FOR MYELOMA PATIENTS FOLLOWING FDA APPROVAL FOR MDS

Revlimid from the Celgene Corporation was just approved by the Food and Drug Administration to treat certain patients with a malignant blood condition called MDS.


ECOG REVLIMID® TRIAL HAS RESUMED
The IMF today is pleased to inform physicians, patients and their families that the clinical trial of Revlimid® plus dexamethasone in people newly diagnosed with multiple myeloma has resumed.

FDA postpones approval of Revlimid® for MDS
But Celgene says filing for myeloma remains on track
The IMF is pleased to report that, according to Celgene, plans to seek FDA approval of Revlimid® to treat multiple myeloma remain unchanged.

GREAT NEWS: Revlimid® Phase III Myeloma Trials to Be Unblinded Early!
Celgene Corporation reported that Revlimid, also known as lenalidomide, has shown outstanding results in the treatment of relapsed or refractory myeloma in two Phase III clinical trials

So, What's Up with Revlimid? Report from ASCO 2005
The Unknown Patient reports from the annual meeting of the American Society of Clinical Oncology (ASCO) on the current status and potential availability of the promising new drug, Revlimid.

Celgene’s Revlimid® (lenalidomide) Exceeds Expectations in Relapsed and Refractory Myeloma
An Independent Data Monitoring Board has advised Celgene to unblind two Phase III clinical trials of Revlimid (lenalidomide) in patients with relapsed or refractory myeloma involving over 700 patients. The results are positive and exceed original expectations.

Revlimid® Phase III Myeloma Trials to Be Unblinded Early
Celgene Corporation reported that Revlimid, also known as lenalidomide, has shown outstanding results in the treatment of relapsed or refractory myeloma in two Phase III clinical trials.