Oncology Product Guide » Leukemia

BioSante Announces FDA Orphan Drug Designation For GVAX Chronic Myeloid Leukemia Cancer Vaccine

Jim Marino — Fri, 11 Jun 2010 11:45:28 +0000

BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.

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SFDA Approves Leukemia BCR/ABL Fusion Gene Detection FISH Probe

Jim Marino — Thu, 19 Nov 2009 14:24:13 +0000

China Medical Technologies, Inc. has announced that the Company has received approval for its Leukemia BCR/ABL fusion gene detection FISH Probe (the “Leukemia BCR/ABL FISH Probe”) from the State Food and Drug Administration of China (the “SFDA”). The Leukemia BCR/ABL FISH Probe is a molecular diagnostic test kit that uses DNA probes for accurate detection of Philadelphia translocation, which is a specific chromosomal abnormality associated with chronic myelogenous leukemia.

New drug ‘can kill leukaemia’

Jim Marino — Thu, 05 Nov 2009 11:49:57 +0000

Scientists from Trinity College Dublin (TCD) have discovered a new drug that can destroy cancerous cells in adult leukaemia patients who have developed resistance to other treatments. During the study, PBOX-15 was found to attack and break down the skeleton in leukaemia cells in samples given by patients. It was also found to effectively treat Chronic Lymphocytic Leukaemia (CLL), which is the most common leukaemia in the western world in adults.

Spectrum Pharma receives FDA approval for Zevalin

Jim Marino — Thu, 17 Sep 2009 03:46:12 +0000

Spectrum Pharmaceuticals Inc has received the FDA approval for its Zevalin as a treatment for non-Hodgkin’s lymphoma, a blood cancer. Zevalin was previously used only for patients who had tumors that had not responded to other treatments. The FDA approval was granted on the basis of a phase-three study in which 414 patients showed partial or complete response after receiving a first-line chemotherapy regimen and Zevalin.

FDA delays Genesense approval

Jim Marino — Thu, 07 Aug 2008 18:54:12 +0000

The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker Genta said. CDER has asked the company to come up with confirmatory evidence for the drug.