The Lynx Group

Leukemia

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication.
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On March 30, 2021, the FDA approved a new indication for daunorubicin and cytarabine (Vyxeos; Jazz Pharmaceuticals) for the treatment of pediatric patients aged ≥1 years with newly diagnosed, therapy-related acute myeloid leukemia (AML) or patients with AML and myelodysplasia-related changes. Daunorubicin and cytarabine is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine).
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Induction chemotherapy leads to remission in many patients with acute myeloid leukemia (AML) aged ≥60 years; however, the disease relapses in the majority of the patients, and the overall survival (OS) is poor. For patients who are not candidates for hematopoietic stem-cell transplant, effective maintenance treatments for AML are needed that can reduce the risk for relapse and improve OS, without causing unacceptable adverse events or compromising quality of life.
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Asciminib, an investigational first-in-class STAMP (specifically targeting the ABL myristoyl pocket) inhibitor, was superior to standard treatment with bosutinib (Bosulif) in patients with chronic-phase chronic myeloid leukemia (CML) who previously received 2 or more tyrosine kinase inhibitors (TKIs) in the phase 3 ASCEMBL clinical trial. The results were presented at a late-breaker session at ASH 2020 by lead investigator Andreas Hochhaus, MD, Director, Department of Hematology and Oncology, Klinik für Innere Medizin II, Jena, Germany.
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Maintenance therapy with azacitidine (Onureg) tablets improved overall survival (OS) in patients with acute myeloid leukemia (AML) who were in remission after intensive chemotherapy in the phase 3 QUAZAR AML-001 study. Survival was extended regardless of the patients’ measurable residual disease (MRD) status at study entry, reported Gail J. Roboz, MD, Director, Clinical and Translational Leukemia Program, Weill Medical College of Cornell University, New York, NY, at ASH 2020.
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The randomized phase 2 CAPTIVATE clinical trial showed that first-line therapy with ibrutinib (Imbruvica) and venetoclax (Venclexta) for a fixed duration (ie, 12 cycles) led to a 30-month progression-free survival (PFS) in more than 95% of patients with chronic lymphocytic leukemia (CLL) and undetectable minimal residual disease (MRD). The results of the MRD cohort of the study were presented at ASH 2020.
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The combination of 2 novel agents—umbralisib and ublituximab (U2)—represents a promising new treatment option for patients with chronic lymphocytic leukemia (CLL). In the phase 3 multicenter clinical trial UNITY-CLL, the median progression-free survival (PFS) was significantly longer with U2 than with standard-of-care chemoimmunotherapy, reported John G. Gribben, MD, DSc, FRCP, Centre Lead, Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, England, at ASH 2020.
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On September 1, 2020, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.
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Targeted therapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence), which is currently approved for the treatment of patients with non-Hodgkin lymphoma, has demonstrated durable remissions in treatment-naïve patients with chronic lymphocytic leukemia (CLL), according to the long-term data from the phase 2 CLL-001 study, which were presented at the ASCO 2020 virtual annual meeting.
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A total of 80% of patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL) achieved a complete response (CR) to axicabtagene ciloleucel (Yescarta), and those responses have proved durable, according to the interim results of the phase 2 ZUMA-5 study, said Caron A. Jacobson, MD, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute, Boston, MA, at the ASCO 2020 virtual annual meeting.
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