FDA places SB-generated CAR T-cell therapy on clinical hold

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T cells
Image from NIAID
The US Food and Drug Administrated (FDA) placed a clinical hold on the phase 1 trial of the Sleeping Beauty (SB)-generated CAR T-cell therapy in relapsed or refractory leukemia and lymphoma patients. The Sleeping Beauty platform was designed to very rapidly manufacture CD19-specific CAR T cells at the point... [Read Article]
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‘Excellent’ survival with HCT despite early treatment failure in FL

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Micrograph showing
follicular lymphoma
Autologous and allogeneic hematopoietic stem cell transplantation (HCT) both offer excellent long-term survival in follicular lymphoma (FL) patients who experience early treatment failure, an analysis of a large transplant registry suggests. Five-year survival rates exceeded 70% for patients who received autologous or matched sibling donor (MSD) transplants, according to... [Read Article]
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PU-H71 receives orphan drug designation for myelofibrosis

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Micrograph showing myelofibrosis
The US Food and Drug Administration (FDA) has granted orphan drug designation to PU-H71 to treat patients with myelofibrosis. The drug specifically targets the epichaperome, a network of high-molecular- weight complexes found in multiple diseases, including cancer and neurologic disorders. These complexes enhance cellular survival, irrespective of tissue of origin or... [Read Article]
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FDA grants pembrolizumab accelerated approval for PMBCL

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Pembrolizumab (Keytruda)
Photo courtesy of Merck
The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL). The indication also includes patients who have relapsed after 2 or more prior lines of... [Read Article]
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Mircera approved for anemia in pediatric patients with CKD

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Red blood cells
Mircera®, methoxy polyethylene glycol-epoetin beta, was approved by the US Food and Drug Administration (FDA) to treat anemia in pediatric patients who have chronic kidney disease (CKD). The drug is indicated for patients ages 5 to 17 years on hemodialysis who are switching from another erythropoiesis-stimulating agent (ESA) after their hemoglobin levels... [Read Article]
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FDA approves venetoclax for CLL/SLL with or without del 17p

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First month’s supply of
venetoclax
Photo courtesy of Abbvie
The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received 1 prior therapy. The combination is approved for patients with or without... [Read Article]
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Dasatinib outcomes similar to imatinib in pediatric Ph+ ALL

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Child with leukemia
Photo by Bill Branson
Dasatinib used during induction and consolidation in the Children’s Oncology Group (COG) AALL0622 trial provided early response rates for children with Ph-positive (Ph+) acute lymphoblastic leukemia (ALL), according to investigators. But the early response rates did not improve event-free survival (EFS) compared to the use of consolidation... [Read Article]
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Emicizumab granted priority review for hemophilia A without inhibitors

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Bleeding human finger
By Crystal (Crystl) from Bloomington, USA - Flickr
The US Food and Drug Administration (FDA) has granted priority review for emicizumab (Hemlibra®) for adults and children with hemophilia A without factor VIII inhibitors. Earlier this year, the agency awarded emicizumab breakthrough therapy designation for the same population. Emicizumab is a bispecific factor... [Read Article]
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FDA approves first biosimilar pegfilgrastim

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Vials and a syringe
The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®. The agents reduce the risk of infection or the duration of febrile neutropenia in patients treated with immunosuppressive chemotherapy for non-myeloid hematologic malignancies. The FDA approved Fulphila based on evidence that included extensive... [Read Article]
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