Navigation Links
Lenalidomide, Granted Approval by FDA to Join Multiple Myeloma Drugs

Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance said that FDA’s approval of REVLIMID (lenalidomide) offered a new oral drug option// to the group of people suffering from multiple myeloma.

Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Supplemental New Drug Application (sNDA) for an additional indication for REVLIMID (lenalidomide), for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. 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. Multiple myeloma is the second most common blood cancer in the United States, affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 12,000 Americans are expected to die of multiple myeloma in 2006. In the REVLIMID (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3 or 4 adverse events were more frequent in patients who received the combination of REVLIMID (lenalidomide)/dexamethasone compared to placebo /dexamethasone.

‘The FDA approval of REVLIMID offers a new oral therapeutic option to this particular group of patients with multiple myeloma,’ said Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance for Celgene. REVLIMID will be available in the following strengths: 5 mg, 10 mg, 15 mg, and 25 mg capsules.

Source: Eurekaler
'"/>




Page: 1

Related medicine news :

1. Bail Granted To The Doctor Despite Her Patients Death
2. Azerbaijan Granted 5 million dollars in Fight Against Bird Flu
3. Developer Of Vaccine For Cancer Granted A Prestigious Fellowship
4. American Senior Citizens Granted More Time
5. Numerous Defense Personnel Granted Early Retirement Due to Mental Illness
6. Approval for DNA test to detect cystic fibrosis
7. Vaccine For Cervical Cancer Awaits Approval
8. WHO Gives Its Approval For Bird Flu Test Kit
9. FDA Gives Its Approval For Inhaler
10. RotaTeq Gets US Approval
11. Better Communication With FDA Could Speed Up Approval Of New Drugs
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, 2016 ... mobile pulmonary function testing company, is now able to perform sophisticated ... by ndd Medical Technologies , Inc. Patients ... hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients ... get any needed testing done in the comfort of her own ...
(Date:6/24/2016)... June 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... innovative inhaled drugs, announced today that it was added ... reconstituted its comprehensive set of U.S. and global ... is an important milestone for Pulmatrix," said Chief Executive ... awareness of our progress in developing drugs for crucial ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology: