FDA Alerts
FDA Approves Lenalidomide
On June 5, 2013, the US Food and Drug Administration approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
FDA Approves Pomalyst for Advanced Multiple Myeloma
The US Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
FDA Approves Gleevec for Children With Acute Lymphoblastic Leukemia
The US Food and Drug Administration today approved a new use of Gleevec ( imatinib ) to treat children newly diagnosed with Philadelphia chromosome positive ( Ph +) acute lymphoblastic leukemia (ALL).
FDA approves Iclusig to treat two rare types of leukemia
The US Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.
Synribo for Chronic Myelogenous Leukemia Approved by FDA
The US Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda
Cephalon , Inc. is voluntarily recalling Treanda ® ( bendamustine HCL ) for Injection 25mg / 8mL ; lot TB30111 , expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.
FDA Drug Safety Communication: Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris ( brentuximab vedotin ).
FDA Drug Safety Communication: Revlimid
The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid ( lenalidomide ) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.
FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their...
FDA Drug Safety Communication: TNF blockers
The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as h epatosplenic T-Cell lymphoma or HSTCL ), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor ( TNF ) blockers, as well as with azathioprine , and/or mercaptopurine .
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, wei...