HEMATOLOGY

General Cancer

<em>FLT3</em> mutation analysis in laboratories has brought on reimbursement barriers in clinical oncology. Jordan Clark, chief commercial officer, Diaceutics, a diagnostic development and commercialization company, spoke to <em>Targeted Oncology</em> about the cause of reimbursement issues and how the problem affects all parties involved.

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.

Biomarker expansion has enjoyed a boom since 2006, with patient incidence of positive biomarkers reaching up to 50% in non&ndash;small cell lung cancer and melanoma and 25% in acute myeloid leukemia and myelodysplastic syndromes, according&nbsp; to the <em>Global Oncology Trends 2018</em> report.

At 3 years of follow-up, the combination of acalabrutinib and obinutuzumab continued to show benefit in patients with both newly diagnosed chronic lymphocytic leukemia and relapsed or refractory disease.

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory chronic lymphocytic leukemia, Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric ASCEND study, testing acalabrutinib monotherapy in comparison with physician&rsquo;s choice of standard regimens in patients R/R CLL.

The FDA approved a supplemental New Drug Application for avatrombopag as a treatment for adult patients with chronic immune thrombocytopenia who have had an insufficient response to a prior therapy.

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;

Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with&nbsp;high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib.&nbsp;Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.&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.