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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 approves glucarpidase injection for treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function

January 17, 2012


FDA has approved changes to methotrexate package inserts

December 20, 2011


FDA approves asparaginase Erwinia chrysanthemi as a component of a chemotherapeutic regimen for treatment of ALL patients with hypersensitivity to E. coli-derived asparaginase

November 18, 2011


FDA approves ruxolitinib for treatment of intermediate and high risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis

November 16, 2011


FDA approves cetuximab in combination with platinum-based therapy plus 5-florouracil (5-FU) for the first-line treatment of patients with recurrent/metastatic SCCHN

November 7, 2011


FDA grants accelerated approval to deferiprone, an oral iron chelator for the treatment of patients with transfusional iron overload

October 14, 2011


FDA makes changes made to the bevacizumab package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event

September 30, 2011


FDA grants accelerated approval for the use of eculizumab for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS)

September 23, 2011


FDA approves new indications for denosumab

September 16, 2011


FDA grants accelerated approval to crizotinib (XALKROI) Capsules with companion diagnostic for a type of late-stage lung cancer

August 26, 2011

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