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Topic: Revlimid

	Revlimid®
		In a recent trial of Revlimid in previously untreated patients with myeloma, aspirin appeared to be successful as prophylaxis, although further studies in larger numbers of patients are necessary for formal recommendations.
		Revlimid® was awarded Fast Track designation for relapsed and refractory myeloma in February 2003, which means that the FDA will facilitate and expedite the development and review of the application.
		Revlimid is being evaluated in combination with Doxil® (liposomal doxorubicin, Ortho-Biotech), vincristine, and reduced frequency dexamethasone (DVd) in relapsed and refractory myeloma in a Phase I/II study at the Cleveland Clinic.
	www.multiplemyeloma.org /treatments/3.08.02.html (2626 words)

	Revlimid™ Promising for Treatment of Multiple Myeloma (Site not responding. Last check: 2007-10-12)
		Revlimid™ is a derivative of thalidomide, which is a very active agent for the treatment of multiple myeloma but has serious side effects, especially thromoembolism.
		Revlimid™ is reported to have less toxicity than thalidomide but retains antimyeloma effects.
		Revlimid™ is in clinical trials for the evaluation of treatment for other hematologic cancers besides MDS.
	professional.cancerconsultants.com /oncology_main_news.aspx?id=34003 (629 words)

	Revlimid Information from Drugs.com
		Revlimid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy.
		Never give Revlimid to another person, even if he or she has the same disorder for which you are being treated.
		Revlimid should be used exactly as your doctor has prescribed it for you.
	www.drugs.com /revlimid.html (1793 words)

	REVLIMID(R) Granted Approval By FDA For Treatment Of Multiple Myeloma
		REVLIMID is also approved for use in the treatment of patients with transfusion-dependent anemia due to Low-or- Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
		REVLIMID is indicated for use as a treatment in combination with dexamethasone for previously treated multiple myeloma.
		REVLIMID is also indicated for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
	www.medicalnewstoday.com /medicalnews.php?newsid=46445&nfid=rssfeeds (1566 words)

	Revlimid® Plus Dexamethasone for Relapsed Multiple Myeloma Promising (Site not responding. Last check: 2007-10-12)
		Revlimid is a derivative of thalidomide, which is a very active agent for the treatment of multiple myeloma but has serious side effects, especially thromboembolism.
		Revlimid prevents the growth of arteries and capillaries that carry nutrients to cancer cells.
		Revlimid was given at a dose of 25 mg orally on days 1-21 with a week of rest and repeated for 4 cycles.
	professional.cancerconsultants.com /oncology_main_news.aspx?id=35740 (706 words)

	Revlimid (lenalidomide)
		Revlimid is structurally similarto thalidomide, a drug known to cause severe birth defects.
		Revlimid (lenalidomide) is approved to treat a subgroup of patients with Myelodysplastic Syndrome (MDS).
		Revlimid will be available by prescription only from physicians and can be filled only by a limited number of specialty pharmacies.
	www.zhion.com /drug/Revlimid.html (1462 words)

	Revlimid® Shows Activity in Chronic Lymphocytic Leukemia
		Revlimid is an agent that has recently been approved for the treatment of myelodysplastic syndromes.
		Revlimid is thought to have properties that stimulate the immune system to fight cancer.
		The researchers concluded that Revlimid appears to be a promising agent in the treatment of CLL that has stopped responding to standard therapies.
	patient.cancerconsultants.com /news.aspx?id=36031 (613 words)

	Revlimid Blog (Site not responding. Last check: 2007-10-12)
		Revlimid is more potent in fighting cancer and has fewer side effects than thalidomide, and tests have shown the drug does not cause birth defects.
		Revlimid is now approved by the FDA for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
		Revlimid has the potential to become a blockbuster with potential sales greater than a billion, based primarily on a strong uptake of the product in multiple myeloma and a modest contribution from MDS patients.
	www.ambers-website.info /revlimid/index.shtml (4633 words)

	i-Newswire.com - Press Release And News Distribution - Revlimid(R) Delays Time to Disease Progression in Previously ... (Site not responding. Last check: 2007-10-12)
		REVLIMID and HDD are given in 28-day cycles REVLIMID 25 mg once daily on Days 1-21 every 28 days, and HDD 40 mg on Days 1-4, 9-12 and 17- 20 every 28 days.
		Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including, multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes as well as solid tumor cancers.
		REVLIMID is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
	i-newswire.com /pr21239.html (1555 words)

	Revlimid approved by the FDA (Site not responding. Last check: 2007-10-12)
		Revlimid® (lenolidomide) approved by the FDA for patients with a subgroup of myelodysplastic syndromes (MDS).
		Revlimid® is an oral medication approved for the treatment of low-or intermediate-risk MDS associated with deletion of 5q, a chromosomal (cytogenetic) abnormality, with or without other cytogenetic abnormalities.
		Revlimid® is expected to be available for distribution in early 2006.
	aplastic-anemia.org /aplastic-anemia-news/aplastic-anemia-news-0093.htm (576 words)

	Revlimid OK'd for Rare Blood Disorder
		Revlimid treats a type of MDS involving a certain genetic abnormality.
		Revlimid structurally resembles another drug, thalidomide, which is known to cause severe birth defects.
		Revlimid will get a "fl box" warning about preventing fetuses from being exposed to Revlimid.
	www.webmd.com /content/article/116/112298?src=RSS_PUBLIC (247 words)

	Celgene Can't Shake Revlimid Critics
		But such assurances of Revlimid's safety did not necessarily gibe with some of the other data presented Sunday, nor did they assuage critics who believe the company is glossing over Revlimid's safety problem and hiding the fact that more of the deaths in the study are being caused by the toxic effects of the drug.
		The two patients in the study whose deaths were tied to Revlimid died because the drug caused a drastic reduction in their white blood cells (neutropenia), red blood cells (anemia) and platelets (thrombocytopenia).
		Given that Revlimid lowers blood counts and makes patients susceptible to serious infection, Celgene critics question how only two deaths are being tied to the drug.
	www.thestreet.com /pf/comment/adamfeuerstein/10197434.html (1014 words)

	Products
		In June 2006, the FDA approved REVLIMID in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
		The approval of FOCALIN XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents, and children diagnosed with ADHD.
		The strong and growing revenue base represented by REVLIMID, THALOMID, ALKERAN, FOCALIN and the RITALIN family of drugs will provide the financial strength to propel the successful development of new products for multiple indications that Celgene is committed to introduce over the next several years.
	www.celgene.com /Products.aspx (435 words)

	REVLIMID improves overall survival and delays disease progression in multiple myeloma patients
		REVLIMID and HDD are given in 28-day cycles: REVLIMID 25 mg once daily on days 1-21 every 28 days, and HDD 40 mg on days 1-4, 9-12 and 17-20 every 28 days.
		Pulmonary embolism occurred in 4.0 percent and 2.9 percent of patients treated with REVLIMID plus dexamethasone, compared to 1.1 percent and 0.6 percent of patients treated with placebo plus dexamethasone in the International and North American trials, respectively.
		REVLIMID is a member of a group of proprietary novel compounds, IMiDs® that are being evaluated by Celgene as a treatment for a broad range of hematology and oncology conditions, including; multiple myeloma, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia as well as solid tumor cancers.
	www.eurekalert.org /pub_releases/2005-12/wsw-rio121205.php (1157 words)

	EHS: Mosby's Drug Consult - Drug News - New Drug Approval Updates 2005
		Revlimid (lenalidomide) has demonstrated significant risk of deep vein thrombosis and pulmonary embolism in some patients with certain medical conditions.
		Revlimid is contraindicated in patients who have demonstrated hypersensitivity to the drug or its components.
		Revlimid is substantially excreted by the kidney, so the risk of toxic reactions may be greater in patients with impaired renal function.
	www.mosbysdrugconsult.com /DrugConsult/newapp2005.html (18178 words)

	Revlimid results look promising for multiple myeloma patients (Site not responding. Last check: 2007-10-12)
		In addition to providing research funding to support Revlimid, the MMRF has worked closely with Celgene and the centers that moved the study forward to assist their efforts to expedite the Revlimid trial, with thousands of individuals directed to the trials via the MMRF's Clinical Trials Monitor (CTM) program.
		Celgene is evaluating treatments with Revlimid for a broad range of hematology and oncology conditions, including: multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) as well as solid tumor cancers.
		Revlimid (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
	www.news-medical.net /?id=8269 (457 words)

	Celgene Corporation :: FDA Grants Priority Review for REVLIMID(R) sNDA for Treatment of Relapsed or Refractory Multiple ... (Site not responding. Last check: 2007-10-12)
		The REVLIMID sNDA submission is based upon the safety and efficacy results of two large randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating REVLIMID plus dexamethasone in multiple myeloma patients that have received at least one prior therapy.
		REVLIMID is approved by the FDA for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
		REVLIMID is not approved by the FDA or any other regulatory agencies as a treatment for any other indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
	sev.prnewswire.com /biotechnology/20060303/NYF01303032006-1.html (1321 words)

	Oncology - FDA Grants REVLIMID® NDA Approval (Site not responding. Last check: 2007-10-12)
		Celgene Corporation (NASDAQ: CELG) announced that the FDA granted approval of REVLIMID (lenalidomide) which is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
		REVLIMID® (lenaliodomide) is substantially excreted by the kidney, so the risk of toxic reactions may be greater in patients with impaired renal function.
		REVLIMID is a member of a proprietary group of novel IMiDs®, immunomodulatory drugs.
	www.medicalnewstoday.com /medicalnews.php?newsid=35493 (1152 words)

	Pill Fights Deadly Blood Disorder
		Revlimid not only can eliminate the need for transfusions in some people with a deadly blood disorder but also can wipe out all signs of the disease in some of them.
		The experimental drug, Revlimid, is being tested in people with myelodysplastic syndrome, or MDS, a group of disorders caused by the bone marrow not making enough healthy, mature blood cells.
		Most are treated with transfusions and growth factors to improve their blood counts and decrease symptoms.
	www.webmd.com /content/Article/106/108062.htm (322 words)

	FDA Grants REVLIMID(R) NDA Approval (Site not responding. Last check: 2007-10-12)
		REVLIMID will be available through a REVLIMID Education and Prescribing Safety Program, called RevAssist(SM) via contracted pharmacies.
		The safety profile for REVLIMID has shown that neutropenia and/or thrombocytopenia were the most common adverse event (AE) and that patients may require a dose adjustment.
		Celgene continues to evaluate treatments with REVLIMID for a broad range of hematology and oncology conditions.
	www.docguide.com /dg.nsf/PrintPrint/CA59A8366B0DCF56852570E500529E8F (972 words)

	REVLIMID: Segmentation Page
		Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function.
		Nursing mothers: It is not known whether REVLIMID
		Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
	www.revlimid.com (604 words)

	International Myeloma Foundation
		We are pleased that REVLIMID has been approved, but we are concerned about the high cost of cancer therapies in the current reimbursement environment.
		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.
		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.
	www.myeloma.org (1076 words)

	MMSupport.net - Home
		ATLANTA, June 5 (Reuters) - Celgene Inc.'s (CELG.O: Quote, Profile, Research) cancer drug Revlimid improves the rate of survival in previously treated patients with the blood cancer multiple myeloma by at least a year compared with those taking standard treatment, according to data released on Monday.
		Data from a late-stage or Phase III clinical trial presented at the annual meeting of the American Society of Clinical Oncology in Atlanta showed that patients who took Revlimid plus chemotherapy lived at least a year longer than those who took chemotherapy plus a placebo.
		Results from two large phase III randomized, double-blinded, placebo-controlled trials indicate that the addition of Revlimid (lenalidomide) to high-dose dexamethasone (HDD) significantly delays time to cancer progression in patients with previously treated multiple myeloma.
	www.mmsupport.net (1072 words)

	Revlimid(R) Promising for Treatment of Multiple Myeloma
		Revlimid® is a derivative of thalidomide, which is a very active agent for the treatment of multiple myelona but has serious side effects.
		Revlimid™ is reported to have less toxicity than thalidomide, but its anti-tumor effect is similar.
		Revlimid® has recently been submitted to the FDA for review of treatment of myelodysplastic syndromes (MDS).
	patient.cancerconsultants.com /news.aspx?id=33923 (743 words)

	Multiple Myeloma
		This process does require not one drug but a combination of these agents to control, and destroy the cancerous cell.
		For example Lenalidomide (Revlimid) and Thalidomide intervene on several pathways and act on different levels making it difficult for the multiple myeloma cell to survive or support its own survival.
		Moreover the activity of traditional drug therapy combinations such as DVd and other chemotherapeutic compounds are significantly enhanced with tolerable side effect profile.
	www.clevelandclinic.org /myeloma (771 words)

	The Multiple Myeloma Research Foundation (MMRF)
		The MMRF applauds the FDA approval of REVLIMID® (lenalidomide) for the treatment of relapsed or refractory multiple myeloma as it represents an important step forward for the treatment of multiple myeloma.
		To hear about recent data presented on REVLIMID, click here.
		To read a press release on the announcement, click here.
	www.multiplemyeloma.org (51 words)

	Medication Guide (Site not responding. Last check: 2007-10-12)
		You should have your blood tested every week during your first 8 weeks of treatment, and at least monthly after that.
		Male patients, even those who have had a vasectomy, must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant.
		Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides.
	www.revlimid.com /medguide.aspx (1765 words)

	FDA grants REVLIMID® NDA approval
		Celgene Corporation (NASDAQ: CELG) announced that the U.S. Food and Drug Administration (FDA) granted approval of REVLIMID (lenalidomide) which is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
		The conference call will be available by web cast at www.celgene.com.
		For more information, please visit the Company's website at www.celgene.com.
	www.eurekalert.org /pub_releases/2005-12/wsw-fgr122805.php (1107 words)

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