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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 approved romidepsin for injection (ISTODAXR) for the treatment of CTCL in patients who have received at least one prior systemic therapy

November 5, 2009


FDA approved ofatumumab (ArzerraT) for the treatment of patients with CLL refractory to fludarabine and alemtuzumab

October 26, 2009


FDA approved pazopanib tablets (VOTRIENT) for the treatment of patients with advanced renal cell carcinoma

October 19, 2009


FDA approved rasburicase (Elitek) for the initial management of plasma uric acid levels in adult patients with leukemia, lymphoma, and solid tumor malignancies

October 16, 2009


FDA grants accelerated approval for pralatrexate injection (FOLOTYNT) for relapsed or refractory PTCL

September 25, 2009


FDA grants approval for the use of bevacizumab (AvastinR, Genentech, Inc.) in renal cell cancer

August 4, 2009


FDA approved Class Labeling for KRAS Mutations to monoclonal antibodies

July 21, 2009


FDA approves pemetrexed (AlimtaR) for maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer patients with no disease progression after four cycles of platinum-based first-line chemotherapy

July 2, 2009


FDA approved new iron replacement product: ferumoxytol (Feraheme Injection)

July 1, 2009


FDA issues alert on safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva (erlotinib)

May 8, 2009

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