Chronic Myeloid Leukemia

Arsenic trioxide (Trisenox) has been approved by the FDA in&nbsp;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.

Acute 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.

The 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 /> &nbsp;

Managing Relapsed Chronic Myeloid Leukemia

Bosutinib (Bosulif) has been approved by the FDA as a first-line treatment for&nbsp;patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

The Leukemia &amp; Lymphoma Society (LLS) has awarded Barbara Savoldo, MD, PhD, with a $600,000, 3-year grant in support of her promising research into a CAR T-cell treatment with a &ldquo;safety switch&rdquo; that could alleviate potential side effects for patients with acute lymphoblastic leukemia being treated with the immunotherapy.

The American Society of Hematology has announced that James R. Downing, MD, of St. Jude Children&rsquo;s Research Hospital will be awarded the 2017 E. Donnall Thomas Lecture and Prize for his discoveries related to the hematopathology and molecular biology of childhood leukemia.

Nilotinib (Tasigna) has been approved by the FDA for the treatment of pediatric patients with&nbsp;Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. The approval is both in the frontline setting and for those with&nbsp;resistance or intolerance to prior therapy, including imatinib.

A supplemental new drug application for bosutinib (Bosulif) has been granted a priority review by the FDA for the first-line treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia. The agency is scheduled to make a final decision by December 2017.<br /> &nbsp;

A supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia has been accepted by the FDA.

In patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase, a 400-mg dose of bosutinib (Bosulif) was associated with higher rates of major molecular response (MMR) and complete cytogenetic response (CCyR) than imatinib (Gleevec).

The Society for Immunotherapy of Cancer (SITC) has announced that Paul M. Sondel, MD, PhD, will receive the 2017 Richard V. Smalley, MD Memorial Lectureship Award.

With treatment for newly diagnosed acute myeloid leukemia remaining essentially unchanged over the last 4 decades, researchers are hopeful that the addition of the investigational agent vadastuximab talirine to standard 7+3 induction therapy may improve survival for these patients.&nbsp;

Miguel Perales, MD, deputy chief, Adult Bone Marrow Transplant Service, and director, Adult Bone Marrow Transplantation Fellowship Program, gives an overview of the PROGRESS II trial in&nbsp;acute leukemia and myelodysplastic syndrome during the ASH Annual Meeting.

The FDA has granted a full approval and label update to ponatinib (Iclusig) for patients with chronic phase (CP), accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Immune checkpoint inhibitor development is progressing as treatments for patients with acute myeloid leukemia and myelodysplastic syndrome, with a number of studies currently assessing new combination strategies.

With a number of effective targeted therapies now available for patients with myeloproliferative neoplasms and chronic myeloid leukemia, patient selection for transplantation should rely heavily on prognostic scoring.

Two-thirds of patients with chronic myeloid leukemia who ceased to receive the TKI treatment imatinib did not relapse after six months, according to Johan Richter, MD, PhD.

Survivors of acute myeloid leukemia (AML) produce antibodies that kill leukemia cells following allogeneic hematopoietic stem cell transplantation (HSCT) that can be used to treat other patients with AML.

Patients with chronic phase chronic myeloid leukemia (CML) can safely conclude treatment of tyrosine kinase inhibitors (TKIs) following a maintained deep molecular remission, according to findings from the large EURO-SKI trial presented at the 2016 European Hematology Association (EHA) Congress.

Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.

The FDA has lifted a clinical hold placed on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).

CPX-351 (Vyxeos) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Multiple targeted therapies have shown promising signs of efficacy for patients with acute myeloid leukemia (AML), including the FLT3 inhibitor midostaurin and novel IDH inhibitors, with the ongoing potential for combination strategies in the future, according to Eytan M. Stein, MD.