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20/01/2005 - New leukemia treatment granted FDA orphan drug status.

On December 28, 2004, the U. S. Food and Drug Administration (FDA) granted marketing approval for clofarabine (Clolar) for treatment of pediatric patients with acute lymphoblastic leukemia. Genzyme Corp. won approval under an accelerated government approval process for products that may offer improvements over existing therapies for serious or life-threatening diseases. Such approvals require studies after a drug's approval to verify clinical benefits. The drug won approval to treat patients aged 1 to 21 who have exhausted other treatment options. The FDA granted Clolar orphan drug status, which provides seven years of market exclusivity for treating pediatric cases of the most common form of childhood leukemia. In mid-stage trials, Genzyme said 20 percent of patients treated with Clolar showed complete remission, while 10 percent of all patients achieved a partial response. Genzyme, which acquired rights to the drug through its acquisition of San Antonio-based Ilex Oncology Inc., said it expects to make Clolar commercially available "as quickly as possible in January 2005". The company said it also will study Clolar for use in treating adult leukemia and solid tumor cancers.

News Archive

3/8/2001 WHY?
17/11/2001 W.H.O. Collaborating Centre for Cancer Control of Uncommon Tumours
10/12/2001 On November 30th, in the hall of the S. Pio X Private Hospital of Milan, Italy, the
18/12/2001 Post-meeting survey
3/12/2002 QUIZ
5/5/2002 Dear Colleagues,Notebook Veri Kurtarma
29/01/2003 New publication on rare cancers !
28/07/2003 Thyroid Cancer Treatment Receives Orphan Drug Status
02/08/2003 Breast cancer in men Kiralık Ofis Ankara
24/09/2003 GISTs: The revolution continues
28/10/2003 Lessons learned from the management of a rare genetic cancer.
17/11/2003 Successful photodynamic therapy for nonresectable cholangiocarcinoma.
07/01/2004 Gene associated with higher risk of melanoma in men
08/03/2004 Susceptibility to Common Adult Cancers in Retinoblastoma Survivors
29/03/2004 FDA Approves First Drug for mesothelioma
25/08/2004 Gene therapy cures malignant melanoma in mice
20/10/2004 FDA grants orphan drug status to two new anticancer drugs.
15/11/2004 New experimental drug for myeloproliferative disorder
28/02/2005 U.S. F.D.A. grants new orphan drug designation for a targeted therapeutic for head and neck cancer.
02/05/2005 Possible targets for a multiple myeloma vaccine
17/10/2005 Orphan drug troxacitabine approved for AML in EU
03/11/2005 FDA designes interleukin 21 as an orphan drug
01/12/2005 Zactima has received FDA orphan drug designation
25/01/2006 CETT Program for Rare Genetic Diseases
23/02/2006 New research studies of multiple myeloma