Mantle Cell Lymphoma

Here's a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

In an interview with 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.

Peter Martin, MD, discusses the differences between subgroups of mantle cell lymphoma. MCL is a heterogenous disease, and in the World Health Organization classification of lymphoid neoplasms, MCL has a leukemia non-nodal presentation, says Martin.

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.

A combination of vorinostat, cladribine, and rituximab demonstrated high, durable rates of complete response in patients with previously untreated mantle cell lymphoma, according to the results of a phase I/II trial of the triplet regimen in patients with non-Hodgkin lymphoma.<br /> &nbsp;

Kieron Dunleavy, MD, discussed current approaches to treating patients with MCL, highlighting peer discussions on the subject and information about the ZUMA-2 trial, in an interview with&nbsp;<em>Targeted Oncology</em>.

Simon Rule, MD, PhD, discusses the current treatment approaches for patients with mantle cell lymphoma in both the United Kingdom and the United States. He says treatment strategies are pretty well established on both sides of the Atlantic Ocean.

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.

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;

The FDA has accepted 6 supplemental Biologics License Applications (sBLAs) for review for a potential update to the dosing schedule for pembrolizumab across several indications.

Ibrutinib as a maintenance therapy for patients with&nbsp;mantle cell lymphoma who respond to frontline induction therapy with or without autologous stem cell transplant appeared safe and feasible, according to the results of a recent study presented at the 2019 ASCO Annual Meeting.

Ezzat Elhassadi, MD, a consultant hematologist at the University Hospital Waterford in Ireland, discusses the therapeutic approach for different subtypes of mantle cell lymphoma. MCL is a spectrum of diseases that should be treated differently, he says.

Lisocabtagene maraleucel demonstrated a promising response rate and an acceptable toxicity profile in the TRANSCEND NHL 001 trial in a cohort of patients with relapsed or refractory mantle cell lymphoma.<br /> &nbsp;

In an interview with <em>Targeted Oncology</em>, Rory McCulloch, MD, discussed the results from a retrospective analysis for R-BAC treatment following relapse on a BTK inhibitor in patients with mantle cell lymphoma.

Copanlisib has been granted with a breakthrough therapy designation from the FDA for the&nbsp;treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.

Preclinical data suggest that the small molecule IACS-10759, which targets the oxidative phosphorylation and glutaminolysis pathways, may play a critical role in overcoming resistance to ibrutinib in mantle cell lymphoma.

In an interview with&nbsp;<em>Targeted Oncology</em>, Ian W. Flinn, MD, PhD, discussed the findings from the phase III BRIGHT trial for patients with MCL. He also highlighted the impact of BR in this patient population and other combinations under active investigation.

Andre Goy, MD, discusses the role of rituximab and bendamustine plus cytarabine as a treatment for patients with mantle cell lymphoma.

Andre Goy, MD,&nbsp;highlighted major controversies being investigated in the field of MCL in terms of patient subgroups and optimal management of each subpopulation.

Clinical outcomes were consistent among transplant-eligible patients with mantle cell lymphoma, regardless of which chemoimmunotherapy induction treatment was administered to the patient.

Andre Goy, MD, discusses a few combinations that are being investigated for the treatment of patients with relapsed/refractory mantle cell lymphoma.

During a&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation, Jonathon B. Cohen, MD, MS, explained to a group of physicians the treatment considerations and decisions he makes when seeing a patient with mantle cell lymphoma in the clinic.

In a recent retrospective analysis, investigators found that initially observing patients with mantle cell lymphoma based solely on clinical criteria was an effective management strategy that did not&nbsp;compromise patient outcomes.

Long-term follow-up findings from the BRIGHT study support the use of bendamustine plus rituximab as a first-line treatment option for patients with indolent non-Hodgkin lymphoma or mantle cell lymphoma.

Andre Goy, MD, discusses the agents he finds most promising for the treatment of patients with mantle cell lymphoma.