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FDA Drug Alerts

In cooperation with the Food and Drug Administrations (FDA) Office of Oncology Drug Products, and as a service to our members, ASCO periodically distributes, via e-mail, notification of recent FDA approvals and other important FDA actions pertaining to therapies for cancer patients. These alerts help the FDA to inform oncologists and other professionals in oncology-related fields of recent approvals and other important FDA actions, in a timely manner. Included in each FDA e-mail is a link to the product label, which provides relevant clinical information on the indication, contraindications, dosing and safety.

Please note that in sending this information, ASCO does not endorse any product or therapy, and does not take any position on the safety or efficacy of the product or therapy described.

For a complete listing of FDA-approved oncology drugs, visit the FDA Approved Oncology Drug website.

 

Year :

 
 

FDA grants accelerated approval to bevacizumab injection (AvastinR, Genentech, Inc.) as a single agent for patients with glioblastoma with progressive disease

May 5, 2009


FDA approves everolimus tablets (AFINITORR, Novartis) for treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib

March 30, 2009


FDA approves Gleevec for adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumor (GIST)

December 19, 2008


FDA approves plerixafor (in combination with G-CSF) to mobilize hematopoietic stem cells in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM)

December 15, 2008


FDA approves Promacta for treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who had an insufficient response to corticosteroids, immunoglobulins

November 21, 2008


FDA approves bendamustine hydrochloride injection

October 31, 2008


FDA converted the approval of denileukin diftitox (OntakR) for the treatment of CTCL from accelerated to regular approval

October 22, 2008


FDA approves Velcade for the initial treatment of patients with Multiple Myeloma

June 24, 2008


FDA approves TREANDA for the treatment of patients with chronic lymphocytic leukemia (CLL)

March 20, 2008


FDA issues safety alert for market withdrawal liquid Leukine (Bayer)

January 25, 2008

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