LYMPHOMAS

The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.

While relapsed/refractory mantle cell lymphoma (MCL) is considered an aggressive disease, new findings show patients may benefit from adding chimeric antigen receptor T-cell therapy to their treatment regimen. ZUMA-2, a currently ongoing trial, aims to understand the potential benefits with axicabtagene ciloleucel, an anti-CD19 CAR T-cell product, for patients with relapsed/refractory MCL.

Enrollment has been halted by the FDA on clinical trials of tazemetostat in patients with various solid tumors and hematologic malignancies, according to Epizyme, the manufacturer of the EZH2 inhibitor.

Selina Chen-Kiang, PhD, a professor of pathology and immunology at Weill Cornell Medical College, discusses the rationale of her phase I trial investigating the use of CDK4/6 inhibitors for the treatment of patients with mantle cell lymphoma.

The B-Cell Lymphoma Moon Shot Program at The University of Texas MD Anderson Cancer Center wants to increase the cure rate of the disease from 30% to 60% within 5 years. In a presentation at the <em>22nd Annual</em> International Congress on Hematologic Malignancies, Michael Wang, MD, detailed results from 3 clinical trials that may help make that 5-year goal into a reality for patients with mantle cell lymphoma.

A novel bromodomain and extra terminal protein inhibitor demonstrated promising early activity and a manageable safety profile in the treatment of patients with relapsed or refractory lymphoma in the results of a first-in-human phase I trial.

The field of mantle cell lymphoma underwent a significant change with the FDA approval of ibrutinib in 2013. Now, the recent approval of&nbsp;acalabrutinib has similarly impacted the treatment landscape, as experts say it could be associated with slightly fewer adverse events than ibrutinib, according to Andre Goy, MD.

There was a 16-week complete response rate of 42% per CT imaging with the combination of venetoclax (Venclexta) and ibrutinib (Imbruvica) in patients with previously untreated or relapsed/refractory mantle cell lymphoma, according to results from the phase II AIM study.

According to results from an extended follow-up of the CheckMate-205 trial looking at patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation,&nbsp;nivolumab (Opdivo) caused an overall objective response rate of 69%.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto)&nbsp;for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here&rsquo;s a look back on the FDA happenings for the month of March 2018.