Cancer Drug Avastin Raises Blood Clot Risk WebMD - Nov 18, 2008 Thalidomide and its sister drug lenalidomide (Revlimid) also block blood vessel growth in cancer patients. Both drugs' labels already carry warnings that ...
Bevacizumab significantly increases venous thromboembolism TheHeart.Org, NY - Nov 18, 2008 Thalidomide and its derivative lenalidomide (Revlimid, Celgene), which both act on VEGF and other factors, have also been associated with this ...
Premium Company Profile - Celgene - New Research Report on ... Live-PR.com (Pressemitteilung), Austria - Nov 14, 2008 Among seven marketed products, the company?s lead product is Revlimid, an analog of thalidomide that is approved by the FDA for the treatment of MDS ...CELG
Celgene: Blockbuster Biotech Bet istockAnalyst.com (press release), OR - Nov 10, 2008 "Revlimid is their blockbuster drug with multi-billion dollar potential. It was first approved by the FDA in 2005, and it has many good years of patent ...CELG
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FDA has approved Revlimid for the treatment of patients with myelodysplastic syndrome linked to deletion 5q
The FDA ( U.S. Food and Drug Administration ) has approved the drug Revlimid ( Lenalidomide ) for the treatment of patients with a subtype of myelodysplastic syndrome ( MSD ).
The subtype is MDS patients with deletion 5q cytogenetic abnormality.
Myelodysplastic syndrome is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells.
Patients with myelodysplastic syndrome may need blood and platelet transfusions and antibiotic therapy for infections.
In clinical trials, patients treated with Revlimid no longer needed transfusions, with most patients becoming independent of transfusion by three months.
The transfusion-free period lasted for an average of 44 weeks.
Myelodysplastic syndrome can develop following treatment with drugs or radiation therapy for other diseases, or it can develop without any known cause.
Some forms of myelodysplastic syndrome can progress to acute myeloid leukemia ( AML ), a type of cancer in which too many white blood cells are made.
An estimated 7,000 to12,000 new cases of myelodysplastic syndrome are diagnosed yearly in the United States.
Although myelodysplastic syndrome occurs in all age groups, the highest prevalence is in people over 60 years of age.
Typical symptoms include weakness, fatigue, infections, easy bruising, bleeding, and fever.
Revlimid is structurally similar to Thalidomide, a drug known to cause severe birth defects.
Additional studies are ongoing in animals to address whether there is a risk that Revlimid will also cause birth defects when taken during pregnancy.
While these studies are under way, Celgene is marketing Revlimid under a risk management plan called RevAssist, designed to prevent fetal exposure.
Under RevAssist, only pharmacists and prescribers registered with the program
will prescribe and dispense Revlimid.
The program requires patients, including female patients undergoing mandatory pregnancy testing, to give informed consent before starting Revlimid.
Physicians are to check pregnancy tests, limit prescriptions to a one-month mail supply, and report any pregnancies to FDA.
FDA and the manufacturer will re-evaluate the risk management plan when results of further animal testing for birth defects are completed.
The labeling for Revlimid will include a Black Box Warning and a Medication Guide regarding the prevention of fetal exposure.
Additional Black Box Warnings include the potential need to lower the dose due to suppressed blood counts and increased risk of blood clots.
Common side effects reported with Revlimid include thrombocytopenia, neutropenia, diarrhea, pruritis, rash, and fatigue.
