DLBCL

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

Overall survival was more than doubled when the CD79b-targeted antibody–drug conjugate polatuzumab vedotin was added to treatment with bendamustine and rituximab for patients with relapsed/refractory diffuse large B-cell lymphoma.

Mosunetuzumab, a CD3 and CD20 bispecific antibody, induced complete remission rates over 30% in patients with relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma or transformed follicular lymphoma, and demonstrated a tolerable safety profile, showing promise for these patients with B-cell indolent and aggressive non-Hodgkin lymphomas. 

According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity in younger patients with low-risk diffuse large B-cell lymphoma. The progression-free survival rates were also similar between the 2 arms. 

After a median of 19 months of follow-up, durable objective response rates were sustained with tisagenlecleucel in patients with relapsed or refractory diffuse large B-cell lymphoma. These updated findings from the phase II JULIET study were presented at the 2018 ASH Annual Meeting. 

The FDA has granted approval to the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy, making it the first biosimilar approved by the FDA for the treatment of patients with NHL.

In an interview with <em>Targeted Oncology</em>, Charalambos Andreadis, MD, MSCE, discussed the use of CAR T-cell therapy in patients with DLBCL, as well as the toxicities associated with each product. He also highlights other promising therapies in the treatment landscape.

Peter Borchmann, MD, discusses the safety signals seen so far in the phase II JULIET trial investigating tisagenlecleucel, a chimeric antigen receptor T-cell therapy, as a treatment option for patients with diffuse large B-cell lymphoma.

Chimeric antigen receptor T-cell therapy has generated new excitment in select hematologic malignancies. Despite recent advances, more research is necessary in order to both move these treatments to earlier settings and drive costs down, Brian Till, MD, noted.

Julie M. Vose, MD, MBA, discusses the importance of conducting genetic testing on all patients with diffuse large B-cell lymphoma to better understand their disease and treat the disease properly.

During a presentation at the National Comprehensive Cancer Network 13th Annual Conference: Hematologic Malignancies Phillippe Armand, MD, PhD, discusses how novel agents could be used in the future either to postpone, permit, or even replace allogeneic stem cell transplantation.

A greater understanding of molecular pathogenesis in non-Hodgkin lymphoma has led to the identification of rational targets for novel small molecule inhibitors, according to Andrew D. Zelenetz, MD, PhD.&nbsp;Combinations of these therapies may also provide greater responses and the potential for therapy&nbsp;discontinuation.

Brentuximab vedotin (Adcetris) has been granted FDA approval for&nbsp;use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma, based on findings from the phase III ECHELON-2 trial.

During the 2018 Association of Community Cancer Centers National Oncology Conference, Olalekan Oluwole, MBBS, MPH, discusses some of the challenges he has encountered with chimeric antigen receptor T-cell therapy.

Selinexor has been granted a fast track designation by the FDA for the&nbsp;treatment of patients with previously treated diffuse large B-cell lymphoma who are ineligible to receive high-dose chemotherapy with stem cell rescue or chimeric antigen receptor T-cell therapy.

The high durable response rates seen with CAR T-cell therapies have helped fill a high unmet need for patients with relapsed/refractory diffuse large B-cell lymphoma, with questions remaining on the optimal way to use these agents following the FDA approval of 2 therapies in the past year, explained Anas Younes, MD, during a presentation at the <em>36th Annual </em>CFS.

Based on findings from the phase III ECHELON-2 trial, brentuximab vedotin (Adcetris) has been submitted to the FDA for approval&nbsp;in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.

With 2 CAR T-cell therapies now approved and more moving quickly through early-phase clinical trials, 4 healthcare experts reflected on the evolving field of CAR T-cell therapy, their understanding of its current and future applicability for patients, the process for administration and the challenges and obstacles that remain unaddressed during an Association of Community Cancer Centers interactive panel.<br /> &nbsp;

David G. Maloney, MD, PhD,&nbsp;reviews the latest developments with CAR T-cell therapy in patients with non-Hodgkin lymphoma.

In a 16-0 vote, the&nbsp;FDA&rsquo;s Oncologic Drugs Advisory Committee has recommended the approval of&nbsp;the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody&rsquo;s non-Hodgkin lymphoma indications.

Guidelines from the International Lymphoma Radiation Oncology Group recommend the use of proton therapy in adults with mediastinal lymphomas and for young women. Specifically, clinicians should consider proton therapy in mediastinal disease that spans below the left main stem coronary artery and is near the front of, behind, or on the left side of the heart.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;September 2018, including several new approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.

Patients with CD30-expressing peripheral T-cell lymphoma who were treated with the combination of brentuximab vedotin and frontline chemotherapy experienced a&nbsp;statistically significant improvement in progression-free and overall survival,&nbsp;according to topline results from the phase III ECHELON-2 trial.

Philip Bierman, MD,&nbsp;discusses the current landscape of central nervous system involvement in aggressive lymphoma and the research that still needs to be conducted.

Antibody&ndash;drug conjugate therapies are making a larger impact on the treatment paradigm for patients with lymphomas, especially following promising data for brentuximab vedotin and inotuzumab ozogamicin.