GI CANCERS

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

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>.

The FDA has approved pembrolizumab monotherapy as a treatment for patients with recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1, as determined by an FDA-approved test, and who have disease progression after &ge;1 prior systemic regimen.&nbsp;

The approval of TAS-102 has been backed by the&nbsp;European Medicines Agency&#39;s Committee for Medicinal Products for Human Use for the treatment of&nbsp;adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, in those previously treated with at least 2 prior systemic therapy regimens for advanced disease.

Laura Dawson, MD, FRCPC, FASTRO, has been selected as the president-elect of the American Society for Radiation Oncology and will begin her term at the society&rsquo;s 61st Annual Meeting, which is being held in Chicago, Illinois on September 15-18.

The FDA has granted an orphan drug designation to MB-102, a CD123-directed CAR T-cell therapy, for the treatment of patients with acute myeloid leukemia.

Pancreatic cancer with&nbsp;<em>BRCA1</em>and&nbsp;<em>BRCA2&nbsp;</em>mutations has shown positive responses to the PARP inhibitor olaparib in preliminary trials.&nbsp;

General Cancer

The investigational agent SM-88 demonstrated promising survival in the phase II TYME-88-Panc study in patients with advanced pancreatic cancer.^1,2&nbsp;The&nbsp;oral modified dysfunctional tyrosine induced a median overall survival of 6.4 months in patients.<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.

In an interview with <em>Targeted Oncology</em>, Shota Fukuoka, MD, PhD, of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, commented on the results of the study and the future plans to expand the research with a larger cohort.

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;