Team creates guidelines on CAR T-cell-related toxicity

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Sattva Neelapu, MD
Photo courtesy of MD
Anderson Cancer Center
Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy. The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to... [Read Article]
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Trials of atezolizumab placed on partial hold

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Atezolizumab (Tecentriq)
Photo from Genentech
Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq). One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma. The other is a phase... [Read Article]
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Application for pegfilgrastim biosimilar withdrawn

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Vials of drug
Mylan S.A.S. has withdrawn the European marketing authorization application for its pegfilgrastim biosimilar Fulphila, according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Fulphila was intended to be used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic... [Read Article]
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FDA approves drug to treat relapsed FL

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Copanlisib (Aliqopa)
PRNewsfoto/Bayer
The US Food and Drug Administration (FDA) has granted accelerated approval to copanlisib (Aliqopa), an intravenous PI3K inhibitor developed by Bayer. The drug is now approved to treat adults with relapsed follicular lymphoma (FL) who have received at least 2 prior systemic therapies. Copanlisib received accelerated approval from the FDA... [Read Article]
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Immune status linked to outcomes of CAR T-cell therapy

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Micrograph showing DLBCL
Outcomes of treatment with a third-generation chimeric antigen receptor (CAR) T-cell therapy are associated with a patient’s immune status, according to a phase 1/2a trial. The CD19-specific CAR T-cell therapy produced a complete response (CR) in 6 of 15 patients with relapsed/refractory CD19-positive leukemia or lymphoma. Though all responders eventually... [Read Article]
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Biosimilar deemed equivalent to reference drug in FL

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Vials of drug
Photo by Bill Branson
The biosimilar GP2013 has demonstrated equivalence to its reference drug rituximab in patients with previously untreated, advanced-stage follicular lymphoma (FL), according to researchers. Treatment with GP2013 plus cyclophosphamide, vincristine, and prednisone (CVP) produced a similar overall response rate (ORR) as rituximab plus CVP in the phase... [Read Article]
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