LYMPHOMAS

Non-Hodgkin Lymphoma

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for patients receiving moderately emetogenic chemotherapy. Additionally, the FDA granted breakthrough therapy designations to 2 therapies, as well as an orphan drug designation, a priority review, and 2 fast track designations.

Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab with lenalidomide had a statistically significant and superior objective response rate compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.

Emerging from the recent 2019 World Conference on Lung Cancer&nbsp;are several notable developments, Robert L. Ferris, MD, PhD, wrote in this issue of&nbsp;<em>Targeted Therapies in Oncology.&nbsp;</em>

Barbara Pro, MD, spoke with a group of physicians during a <em>Targeted Oncology </em>live case-based peer perspectives discussion about the diagnosis, prognosis, and treatment of patients with Hodgkin lymphoma based on the case&nbsp;of a young woman with classic Hodgkin lymphoma.

Marcelo C. Pasquini, MD, discusses the rationale for analyzing real-world data for the use of tisagenlecleucel, a chimeric antigen receptor T-cell therapy, as a treatment for patients with acute lymphoblastic leukemia and diffuse large B-cell lymphoma. This CD19 CAR T cell was approved 2 years ago for use in both ALL and DLBCL.

The FDA has granted duvelisib with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.<br /> &nbsp;

In an interview with&nbsp;<em>Targeted Oncology</em>, Marcelo C. Pasquini, MD, discussed the importance of obtaining real-world data and establishing registries for collecting patient outcomes, and how real-world data compare with data from pivotal trials. He also explained the challenges with accessibility to CAR T-cell therapies.

The FDA has granted a fast track designation to abexinostat for the treatment of patients with relapsed or refractory follicular lymphoma in the fourth-line setting.<br /> &nbsp;

&quot;Early-relapsing lymphoma is a problem, there is no debate about that. The hard part is in trying to manage these patients effectively,&rdquo; Jonathon B. Cohen, MD, MS, told an audience at the 2019 Debates and Didactics in Hematology and Oncology conference held in Sea Island, Georgia.<br /> &nbsp;

In a prospective postmarketing assessment, the use of tisagenlecleucel for treatment of adult patients with diffuse large B-cell lymphoma, lead to responses that were similar to studies of children and adolescents with B-cell acute lymphoblastic leukemia.

Recent updates to the JULIET study, presented at the 2019 SOHO Annual Meeting, show that tisagenlecleucel has sustained benefit throughout the course of the trial with high response rates, and long duration in adults with relapsed/refractory diffuse large B-cell lymphoma.

In a retrospective study of patients with replaced or refractory Hodgkin lymphoma, checkpoint inhibition prior to haploidentical stem cell transplantation improved progression-free survival and risk for relapse, based on results presented at the 2019 SOHO Annual Meeting.

In an interview with <em>Targeted Oncology</em>, Gregorz S. Nowakowski, MD explained the details of the ECOG-ARIN 1412 trial and how the positive results related to patients with DLBCL will further improve outcomes for patients with all lymphoma types.

In an interview with&nbsp;Targeted Oncology, Sattva S. Neelapu, MD, discussed the evolving role for CAR T-cell therapy in patients with B-cell lymphomas. He also highlighted the toxicities commonly associated with these therapies and how physicians can treat these AEs as they arise.

The FDA has granted a New Drug Application for zanubrutinib a priority review for the treatment of patients with mantle cell lymphoma who have previously received at least 1 prior treatment.

In an interview with <em>Targeted Oncology</em>, Chong, a fellow at the University of Pennsylvania, discussed the 4-year follow-up data for CAR T cells in patients with DLBCL and FL. She also addressed the challenges that need to be overcome in order to give more patients access to this type of therapy.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

In an interview with <em>Targeted Oncology</em>, Peter Martin, MD, assistant professor of medicine, Division of Hematology/Oncology, Weil Cornell Medicine, recounts physician crossfire discussions related to frontline MCL treatment and provides his own expert opinion on the subject.

PF-05280586, a biosimilar for rituximab, has been approved by the FDA for use as a single-agent or in combination with chemotherapy for the treatment of&nbsp;adult patients with CD20-positive B-cell non-Hodgkin lymphoma, or in combination with chemotherapy for patients with CD20-positive chronic lymphocytic leukemia.

A single-arm, multicenter phase II trial held in China analyzed the Bruton&rsquo;s tyrosine kinase inhibitor zanubrutinib for treatment of patients with relapsed/refractory mantle cell lymphoma. Previously, the investigational BTK inhibitor gained a&nbsp;breakthrough&nbsp;designation&nbsp;from the&nbsp;FDA&nbsp;based on early results from the phase II trial that showed zanubrutinib to be highly active.<br /> &nbsp;