HEMATOLOGY

The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.

Based on data from the phase II BRIGHT 1003 study, the FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia, according to Pfizer, the developer of the investigational oral smoothened inhibitor.

William B. Donnellan, MD, was recently promoted to director of Leukemia/Myelodysplastic Syndrome Research at the Sarah Cannon Research Institute in Nashville, Tennessee. Donnellan has served as an investigator of hematologic malignancies since 2014 at the Sarah Cannon Research Institute.

An overall response rate of 60% was induced with venetoclax (Venclexta) monotherapy in patients with poor-risk relapsed/refractory mantle cell lymphoma who were previously treated with a BTK inhibitor, according to results presented at the 2018 European Hematology Association Congress. Of the responding patients, 20% had a complete response.

A supplemental new drug application for ibrutinib in combination with rituximab has been granted a priority review by the FDA. According to Pharmacyclics and Janssen Biotech, the codevelopers of ibrutinib, this combination could be a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

According to long-term follow-up data from the phase III CLL11 study, treatment with obinutuzumab combined with chlorambucil reduced the risk of death by 24% versus rituximab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia with comorbidities. These findings were presented at the 2018 European Hematology Association Congress.

In patients with untreated advanced-stage classical Hodgkin lymphoma, PET can be safely used to guide treatment after 2 cycles of upfront de-escalated BEACOPP, according to the final analysis of the phase III LYSA study presented at the 2018 European Hematology Association Congress.

Andre Goy, MD, chief, Division of Lymphoma, chairman and director, John Theurer Cancer Center, discusses the progress made with immunotherapy for the treatment of hematologic malignancies over the last 5 years.

Neil E. Kay, MD, a professor of medicine at the Mayo Clinic, discusses the challenges that arise when treating a patient with relapsed chronic lymphocytic leukemia (CLL). Most times, responses in this setting are short lived.

Matthew S. Davids, MD, MMSc, discusses the findings with duvelisib plus fludarabine-cyclophosphamide-rituximab as a frontline therapy for younger patients with CLL, as well as the potential future for this agent in the treatment of patients with CLL.

Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the European Commission for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.

Michael R. Grunwald, MD,&nbsp;discusses new and emerging agents in AML and ALL, as well as sequencing and toxicity challenges with these treatments.<br /> &nbsp;

Alexander Perl, MD, an associate professor of medicine at the University of Pennsylvania, discusses the current challenges with CAR T-cell therapy for the treatment of patients with acute myeloid leukemia

The biggest clinical unmet need in the treatment of patients with mantle cell lymphoma is overcoming resistance to BTK inhibitors, as patients who progress on treatment with ibrutinib&nbsp;(Imbruvica) and acalabrutinib (Calquence) are often incurable, according to Michael Wang, MD. Investigators are now challenged to find a new avenue of treatment.

An overall response rate of&nbsp;41.6% (95% CI, 32.9-50.8) was induced with the use of ivosidenib in patients with&nbsp;<em>IDH1</em>-positive relapsed/refractory acute myeloid leukemia, according to data presented at the 2018 ASCO Annual Meeting&nbsp;and published simultaneously online in the <em>New England Journal of Medicine</em>.

Pembrolizumab (Keytruda) has been granted&nbsp;an accelerated approval by the FDA&nbsp;for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy.&nbsp;The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE&#8209;170 trial.

Noa Biran, MD, physician, Multiple Myeloma Division, John Theurer Cancer Center, discusses the rationale for selecting stem cell transplant as treatment over a chemotherapy regimen for patients with multiple myeloma.