HEMATOLOGY

The FDA has granted approval to the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy, making it the first biosimilar approved by the FDA for the treatment of patients with NHL.

In an interview with <em>Targeted Oncology</em>, Charalambos Andreadis, MD, MSCE, discussed the use of CAR T-cell therapy in patients with DLBCL, as well as the toxicities associated with each product. He also highlights other promising therapies in the treatment landscape.

Andre Goy, MD, chairman and director, chief of lymphoma, and director of clinical and translational cancer research at John Theurer Cancer Center, discusses data from the RELEVANCE trial, which randomized patients with follicular lymphoma in need of therapy to receive either rituximab plus lenalidomide or a physician&rsquo;s choice of bendamustine and rituximab plus CHOP or R-CHOP.

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.

Mutations in 8 high-risk genes are associated with an acute myeloid leukemia (AML) diagnosis, according to a deep sequencing analysis. Hetty Carraway, MD, said that these findings lay the ground work for upcoming research on early detection and novel treatment strategies.

Patients with acute myeloid leukemia now have more treatment options available than ever, due to some major changes to the field over the last year. With 2 drugs already approved for patients with <em>IDH</em> mutations and 4 new drugs expected to receive approval in the next year, it is a more hopeful time than ever for this patient population.

Ajai Chari, MD, discusses the rationale for using combination therapy in patients with multiple myeloma.&nbsp;

Alexander E. Perl, MD, discusses the use of antibody-drug conjugates in acute myeloid leukemia. Gemtuzumab ozogamicin has already been approved for this patient population.

Blinatumomab has received support from the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use. The agent has been recommended for approval as a treatment of adult patients with&nbsp;B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.

Julie M. Vose, MD, MBA, discusses the importance of conducting genetic testing on all patients with diffuse large B-cell lymphoma to better understand their disease and treat the disease properly.

During a presentation at the National Comprehensive Cancer Network 13th Annual Conference: Hematologic Malignancies Phillippe Armand, MD, PhD, discusses how novel agents could be used in the future either to postpone, permit, or even replace allogeneic stem cell transplantation.

The approval of&nbsp;eltrombopag (Promacta) in combination with standard immunosuppressive therapy has been expanded by the FDA to include&nbsp;newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia, according to Novartis, the manufacturer of eltrombopag.^&nbsp;Eltrombopag was also granted a breakthrough therapy designation&nbsp;as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome.

A greater understanding of molecular pathogenesis in non-Hodgkin lymphoma has led to the identification of rational targets for novel small molecule inhibitors, according to Andrew D. Zelenetz, MD, PhD.&nbsp;Combinations of these therapies may also provide greater responses and the potential for therapy&nbsp;discontinuation.

Brentuximab vedotin (Adcetris) has been granted FDA approval for&nbsp;use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma, based on findings from the phase III ECHELON-2 trial.

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

During the 2018 Association of Community Cancer Centers National Oncology Conference, Olalekan Oluwole, MBBS, MPH, discusses some of the challenges he has encountered with chimeric antigen receptor T-cell therapy.

CLL 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 &ge;65 years of age.&nbsp;As such, treatment, if indicated, is typically conservative.&nbsp;Current CLL treatments are not considered to be curative; however, long-term remission can be achieved in some patients using allogenic stem cell transplantation.

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.

Sarah Holstein, MD, PhD, explains her rationale for choosing a triplet regimen over a quadruplet in patients with multiple myeloma.&nbsp;

A supplemental new drug application (sNDA)&nbsp;for avatrombopag (Doptelet) as a treatment for patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment has been accepted for review by the FDA.

Richard Furman, MD, discusses how survival times for patients with chronic lymphocytic leukemia have increased dramatically in the past decade, thanks to an ever-expanding armamentarium of novel agents and more patients now being diagnosed earlier.

Based on findings from the phase III ECHELON-2 trial, brentuximab vedotin (Adcetris) has been submitted to the FDA for approval&nbsp;in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.