March 12th 2024
The BCR-ABL tyrosine kinase inhibitor TERN-701 has been granted an orphan drug designation from the FDA for the treatment of chronic myeloid leukemia.
December 12th 2023
Community Practice Connections™: Real-World Applications of Novel Therapies Across TNBC and Addressing Disparities in Care
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6th Annual Precision Medicine Symposium: An Illustrated Tumor Board
October 18-19, 2024
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Advances in TNBC: Communicating with Your Patients About Clinical Trial Awareness and Treatment Concerns to Improve Clinical Outcomes
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Current and Emerging Treatment Options in Chronic Lymphocytic Leukemia
November 13th 2018CLL is a malignant disease characterized by progressive accumulation of immature, immunophenotypically distinct lymphocytes in the blood, bone marrow, and lymphatic tissues. Although the clinical course of CLL can be unpredictable, this disease is typically slow-progressing and occurs most often in patients ≥65 years of age. As such, treatment, if indicated, is typically conservative. Current CLL treatments are not considered to be curative; however, long-term remission can be achieved in some patients using allogenic stem cell transplantation.
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Diagnosis, Risk Stratification, and Prognosis in Patients With Chronic Lymphocytic Leukemia
November 13th 2018Chronic lymphocytic leukemia is characterized by the clonal proliferation and accumulation of small, mature-appearing CD5-positive B lymphocytes in the blood, bone marrow, and secondary lymphoid tissues. A CLL diagnosis is established by the presence of more than 5x109/L peripheral lymphocytes co-expressing CD5, CD19, and CD23, and weakly expressing CD20, CD79b, and surface immunoglobulin. Small lymphocytic lymphoma represents a clinical variant of CLL and is similarly managed.
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Dasatinib Granted Approval in Europe for Pediatric Ph+ Chronic Phase CML
July 5th 2018Dasatinib has been granted approval by the European Commission as a treatment for children and adolescent patients aged 1 to 18 years with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, according to Bristol-Myers Squibb, the manufacturer of the tyrosine kinase inhibitor.
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Notable CR Rate Induced by Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
June 4th 2018According to results presented at the 2018 ASCO Annual Meeting, moxetumomab pasudotox, a first-in-class recombinant immunotoxin targeting CD22, demonstrated deep and durable responses in a substantial proportion of pretreated patients with relapsed/refractory hairy cell leukemia.
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A Look Back at FDA News in the Month of April
May 1st 2018The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.
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Nilotinib Granted FDA Approval for Pediatric CML
March 22nd 2018Based on data from 2 clinical trials, nilotinib (Tasigna) has been approved by the FDA for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase.
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Arsenic Trioxide Approved by FDA for Promyelocytic Leukemia
January 17th 2018Arsenic trioxide (Trisenox) has been approved by the FDA in combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.
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Optimizing FLT3 Inhibitor Monotherapy in Acute Myeloid Leukemia
December 27th 2017Acute myeloid leukemia (AML) therapy is guided mainly by cytogenetic profile, such as chromosomal duplication or deletion, and molecular mutations. <em>FLT3</em> mutations are the most common genetic abnormalities detected in patients with AML and are usually associated with a high relapse rate and short overall survival. Given the dismal outcomes in patients with <em>FLT3</em>-mutant AML, a great effort has been underway over the last several years to develop clinically effective FLT3 inhibitors.
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Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
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