LYMPHOMAS

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;

The FDA has granted a fast track designation for CLR 131 as a potential treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. The designation was based on data from the DLBCL cohort of the ongoing phase II CLOVER-1 trial which is investigating CLR 131 in patients with relapsed/refractory B-cell lymphomas.

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.

Lori A. Leslie, MD, discusses the rationale for investigating the PI3K-delta inhibitor umbralisib in patients with relapsed or refractory marginal zone lymphoma in a multi-center, open-label phase II study. On trial, only patients with MZL were enrolled who had received at least 1 prior line of therapy. These patients received single-agent umbralisib once daily until progression or unacceptable toxicity.

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for&nbsp;bevacizumab across several indications.

Lenalidomide plus standard R-CHOP immunochemotherapy may help select patients with activated B-cell-type diffuse large B-cell lymphoma who have a poor prognosis, based on data from the phase III ROBUST trial presented at the 2019 International Conference on Malignant Lymphoma.<br /> &nbsp;

Mitchell Smith, MD, PhD,&nbsp;discussed the most recent research and agents under investigation for the treatment of indolent lymphomas. He also highlighted how conversations transpire when discussing the watch-and-wait approach with his asymptomatic patients.

Hodgkin Lymphoma

A combination of nivolumab plus brentuximab vedotin was highly active in 73% of patients with relapsed/refractory primary mediastinal large B-cell lymphoma, based on results from the phase I/II CheckMate 436 trial, recently announced during the 15th International Conference on Malignant Lymphoma.<br /> &nbsp;