Inhibitor receives orphan designation for PTCL

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Enteropathy-associated
T-cell lymphoma
Image by Michael Bonert
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to cerdulatinib for the treatment of peripheral T-cell lymphoma (PTCL). Cerdulatinib is an oral Syk/JAK inhibitor being developed by Portola Pharmaceuticals, Inc. Preclinical data have suggested an important role for Syk and JAK in PTCL... [Read Article]
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Variant not associated with CLL, AIHA, or ITP in certain patients

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DNA helix
Image by Spencer Phillips
New research suggests there is no association between the PTPN22 R620W polymorphism and chronic lymphocytic leukemia (CLL) or autoimmune hematologic disorders in patients from the Republic of Macedonia. Past studies have shown an association between the PTPN22 R620W variant and both CLL and autoimmune diseases in patients from... [Read Article]
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System may better predict thrombosis in lymphoma

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Audience at Leukemia and Lymphoma: Europe and the USA, Linking Knowledge and Practice
An updated scoring system can more accurately identify lymphoma patients who may require thromboprophylaxis, according to researchers. The revised scoring system, ThroLy, proved more effective than other systems for predicting thromboembolic events in lymphoma patients. Researchers found the updated ThroLy had... [Read Article]
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Weighing the costs of CAR T-cell therapy

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Tisagenlecleucel (Kymriah)
Photo from Novartis
The cost-effectiveness of tisagenlecleucel (Kymriah) depends on long-term clinical outcomes, which are presently unknown, according to investigators. If the long-term outcomes are more modest than clinical trials suggest, then payers may be unwilling to cover the costly therapy, reported John K. Lin, MD, of Stanford University, and his colleagues. Lowering... [Read Article]
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Duvelisib bests ofatumumab as monotherapy for treatment of CLL/SLL

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Ian W. Flinn, MD, PhD
Photo from Sarah Cannon
Final analysis of the phase 3 DUO trial has shown monotherapy with oral duvelisib results in a statistically significant improvement in progression-free survival (PFS) and overall response rate (ORR) compared to monotherapy with ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia/small lympchocytic lymphoma (CLL/SLL).... [Read Article]
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5-year remission rates with combo prove durable in MCL

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Mantle cell lymphoma
Long-term results of a phase 2 clinical trial of the lenalidomide and rituximab combination as first-line therapy for mantle cell lymphoma (MCL) show continued durable responses with manageable toxicities after 5 years. With a median follow-up of 64 months, 21 of 33 patients with initial responses remained in durable, minimal residual disease... [Read Article]
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Ground-breaking therapy comes with distinct challenges

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Attendees at the 13th NCCN
hematology congress
Photo courtesy of NCCN
Two chimeric antigen receptor (CAR) T-cell therapies—axicabtagene ciloleucel (Yescarta ®) and tisagenlecleucel (Kymriah™)—are already approved in B-cell lymphoma by the U.S. Food and Drug Administration. A third, lisocabtagene maraleucel, will most likely be approved before too long. Despite differences, they all have high... [Read Article]
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FDA approves duvelisib for CLL/SLL and FL

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Micrograph showing CLL
The U.S. Food and Drug Administration (FDA) has approved duvelisib (Copiktra™), a dual PI3K delta/gamma inhibitor, for two indications. Duvelisib has full FDA approval to treat adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies. Duvelisib also has accelerated approval to... [Read Article]
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Drug approved as part of frontline therapy for HL

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Brentuximab vedotin
Photo from Business Wire
The Japanese Ministry of Health, Labour and Welfare has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vinblastine, and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma (HL). The approval was based on the phase 3 ECHELON-1 trial. Result from ECHELON-1 were presented at the 2017 ASH... [Read Article]
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CHMP backs proposed biosimilars of pegfilgrastim

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Neulasta Onpro Kit
Photo from Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for three proposed biosimilars of pegfilgrastim—Ziextenzo, Pelmeg, and Fulphila. If approved by the European Commission (EC), these products would be used for the same indication as the reference medicine, Neulasta (pegfilgrastim). Neulasta has been... [Read Article]
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