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On September 14, 2017, the U.S. Food and Drug Administration granted accelerated approval to copanlisib (ALIQOPA™, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
On September 1, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) today issued a statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of KEYTRUDA® (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. KEYTRUDA® (pembrolizumab) is not approved for treatment of multiple myeloma.
On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel (KYMRIAH®, Novartis Pharmaceuticals Corp.) for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
On August 3, 2017, the U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. This is the first FDA-approved treatment specifically for patients with t-AML or AML-MRC.
On August 2, 2017, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.
On August 1, 2017, the U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
On July 7, 2017, the U.S. Food and Drug Administration approved L-glutamine oral powder (Endari™, Emmaus Medical, Inc.) for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older.
On June 23, 2017, the U.S. Food and Drug Administration approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Blood: How I Treat Hematology 2016 ASH Academy ASH On Demand
September 8 - 9, 2017 Chicago, IL
Hear the top experts in hematologic malignancies discuss the latest developments in clinical care and find answers to your most challenging patient care questions.
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by American Society of Hematology