LEUKEMIAS

According to updated data from the phase II ELIANA study, CD19-targeted CAR T-cell therapy tisagenlecleucel as treatment of pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia sustained rates of relapse-free survival and overall survival at 24 and 18 months. 

Gilteritinib has been approved by the FDA&nbsp;for the treatment of adult patients with&nbsp;<em>FLT3</em>&nbsp;mutation&ndash;positive relapsed or refractory acute myeloid leukemia.

A new drug application for&nbsp;quizartinib has been granted a priority review by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia. The designation is based on findings from the&nbsp;phase III QuANTUM-R study.&nbsp;

Glasdegib (Daurismo) has been granted FDA approval for combination use&nbsp;with low-dose cytarabine for the treatment of patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older or who are ineligible for intensive chemotherapy.

Venetoclax (Venclexta) has been granted an accelerated approval by the FDA for combined use with&nbsp;azacitidine or decitabine or low-dose cytarabine as a treatment for&nbsp;adult patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older,&nbsp;or who have comorbidities that preclude use of intensive induction chemotherapy.

<br /> Mary-Beth Percival, MD, discusses the ongoing development of FLT3 inhibitors and other current research in patients with AML.

Susan M. O&rsquo;Brien, MD, discusses the challenges with the 3 oral agents approved in chronic lymphocytic leukemia.

Chronic 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.&nbsp;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.&nbsp;Small lymphocytic lymphoma represents a clinical variant of CLL and is similarly managed.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;October 2018, including several new FDA approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.<br /> &nbsp;

Treatment-na&iuml;ve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.

Sarah K. Tasian, MD, discusses what she finds most interesting about Philadelphia chromosome (Ph-like) acute lymphoblastic leukemia.

A&nbsp;supplemental new drug application for ibrutinib (Imbruvica) has been granted a priority review by the FDA&nbsp;for use in combination with obinutuzumab (Gazyva) as a frontline treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Lloyd Damon, MD,&nbsp;discussed novel therapies in AML with a focus on FLT3 and IDH1/2 inhibitors.<br /> &nbsp;

Danielle Brander, MD,&nbsp;discusses the current treatment landscape in the frontline setting for patients with chronic lymphocytic leukemia.

Shagun Arora, MD, discusses new agents and combination studies beyond chemoimmunotherapy for patients with CLL.

Rami S. Komrokji, MD,&nbsp;reflects on the diverse treatment landscape of AML and touches on the prognostic importance of biomarkers.

Mazyar Shadman, MD,&nbsp;discusses the evolution of therapy in CLL and how physicians are working to balance these novel agents with additional modalities.<br /> &nbsp;

Infographic: Here, we share the top 5 oncology news stories we reported this week, including the most recent FDA updates and expert insights on key developments in the field.

In an interview with <em>Targeted Oncology</em>, Jay Yang, MD, discussed the evolution of the treatment landscape for AML and the future outlook for these treatments.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;September 2018, including several new approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.

The next-generation sequencing assay clonoSEQ has gained FDA approval as a test for minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.

Javier A. Pinilla-Ibarz, MD, PhD,&nbsp;discusses updates in the treatment of patients with chronic lymphocytic leukemia.

In an interview with&nbsp;<em>Targeted Oncology</em>, Katy Rezvani, MD, discussed the potential she sees with CAR NK cells. She also highlighted some of the challenges with both CAR T-cell therapy in patients with CLL, as well as challenges to overcome with CAR NK cells in this patient population.

Duvelisib (Copiktra) has been approved by the FDA for the&nbsp;treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory follicular lymphoma.&nbsp;Both indications are for the treatment of patients who have received at least 2 prior therapies.

Based on data from the phase III MURANO trial, the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use has recommended the approval of venetoclax&nbsp;for patients with chronic lymphocytic leukemia who have received at least 1 previous therapy. AbbVie, a co-developer of venetoclax with Roche, announced the CHMP&rsquo;s decision in a news release.

In an interview with&nbsp;<em>Targeted Oncology</em>, Jorge E. Cortes, MD, discussed the results from the QuANTUM-R trial, as well as some other studies investigating the use of quizartinib in different patient populations in AML.

Javier Pinilla-Ibarz, MD, PhD, senior member of the Department of Malignant Hematology at Moffitt Cancer Center, discusses the current treatment landscape of chronic lymphocytic leukemia.

Adding the combination of venetoclax (Venclexta) and navitoclax (ABT-263) to chemotherapy induced an objective response rate of 66.7% in adults with relapsed/refractory acute lymphoblastic leukemia or lymphoblastic lymphoma, according to results from a small phase I study presented at the 2018 SOHO Annual Meeting.

In a presentation during the 2018 SOHO Annual Meeting, Terry J. Fry, MD, discussed some of the data that have been seen so far with CD19- and CD22-direct CAR T cells, and addressed resistance to these products. &nbsp;

Moxetumomab pasudotox has been approved by the FDA for the&nbsp;treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.