Follicular Lymphoma

Mogamulizumab-kpkc (Poteligeo) has been approved by the FDA as a treatment for patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

In patients with untreated advanced-stage classical Hodgkin lymphoma, PET can be safely used to guide treatment after 2 cycles of upfront de-escalated BEACOPP, according to the final analysis of the phase III LYSA study presented at the 2018 European Hematology Association Congress.

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy. The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE‑170 trial.

An objective response rate was achieved in 18 of 37 patients with relapsed/refractory non-Hodgkin lymphoma who received the combination of the BTK inhibitor ibrutinib with the PI3K inhibitor buparlisib, according to findings of a phase I/II trial reported at the 2018 ASCO Annual Meeting.

The 2018 ASCO Annual Meeting was a great success, with over 40,000 people in attendance and over 5000 abstracts presented from June 1-5 in Chicago, Illinois. Data from several phase III trials in lung cancer were presented, with especially significant results in non–small cell lung cancer. Other big areas during this year’s meeting included breast, gastrointestinal, genitourinary, and hematologic cancers.

Based on data reported at the 2018 ASCO Annual Meeting, the primary endpoint of the phase III RELEVANCE trial was not met with the combination of rituximab plus lenalidomide showing similar efficacy results compared with rituximab plus chemotherapy in treatment-naive patients with follicular lymphoma. The chemotherapy-free regimen, however, did show a more favorable toxicity profile. 

Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.

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.

Voxtalisib (XL765) monotherapy induced objective responses in 41.3% of patients with follicular lymphoma, but displayed minimal efficacy in patients with other lymphomas, according to results from a phase II trial of patients with relapsed or refractory lymphoma or chronic lymphocytic leukemia that were recently published in the Lancet Haematology.

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.

The combination of CC-122, an investigational pleiotropic pathway modulator, and the second-generation anti-CD20 antibody obinutuzumab induced strong responses in patients with relapsed or refractory follicular lymphoma.

A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.

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

Relapsed Follicular Lymphoma