FDA approves Novartis’ cancer-blocking drug Gleevec
ROCKVILLE, Md. The Food and Drug Administration has approved a Novartis drug for use in preventing cancer from growing in patients after surgical removal of gastrointestinal stromal tumors, also known as GIST.
Gleevec (imatinib mesylate) originally received FDA approval in 2001 and is one of the first drugs in a class that blocks cellular communications that result in tumor growth.
“Approval of Gleevec offers healthcare professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses.”
About 5,000 to 6,000 patients in the United States receive GIST diagnoses every year. The cancer can be difficult to detect early because its symptoms are no different than other GI complaints such as nausea and vomiting.
Biosimilars could save significant amounts in healthcare costs, report concludes
ARLINGTON, Va. A report by the Congressional Budget Office on the potential savings that biosimilars could create has drawn a response from the Generic Pharmaceutical Association.
“As Congress grapples with both the economic and healthcare crises facing our nation, the CBO Budget Options Report is concrete evidence that bringing safe, effective and affordable biogenerics to patients can result in significant healthcare cost savings for the federal government,” GPhA president and chief executive officer Kathleen Jaeger said in a statement.
“Specifically, the CBO Budget Options Report states that establishing a pathway for the approval of biogenerics will result in a multi-billion dollar savings potential for the federal government.”
Currently, the law does not permit the Food and Drug Administration to approve biosimilars, sometimes called biogenerics.
FDA approves Genzyme drug to support bone marrow transplant recovery
ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.
Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.
Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.
Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.
“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”