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A look back at all the FDA news that happened in the month of 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 statistically significant improvement in progression-free and overall survival, according to topline results from the phase III ECHELON-2 trial.

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

Antibody–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.

Jonathon B. Cohen, MD, discusses findings from a study of polatuzumab vedotin, an anti-CD79b antibody-drug conjugate, with bendamustine and rituximab in patients with aggressive lymphomas.

During a presentation on diffuse large B-cell lymphoma at the 2018 SOHO Annual Meeting, Thomas E. Witzig, MD, discussed several ongoing trials that hope to raise the cure rate above the 80% threshold.

Pontchartrain Cancer Center was founded in 2005 to serve an area of Louisiana that lacked the necessary resources for cancer care. This community cancer center, with 2 locations in Southeast Louisiana, accommodates any patient to walk through its doors, filling a major unmet need for the community in this rural area.

The partial clinical hold previously placed on trials examining tazemetostat in patients with various solid tumors and hematologic malignancies has been lifted by the FDA and enrollment has been reopened.

Combinations of novel drugs used for treating patients with lymphomas may have the potential to improve responses and overcome resistance to therapy but can be accompanied by unexpected adverse events that demand careful monitoring, Kieron Dunleavy, MD, cautioned during the 2018 Pan Pacific Lymphoma Conference.

Quick progress was seen with a novel class of agents, chimeric antigen receptor T-cell therapies, in the setting of diffuse large B-cell lymphoma—a swift jump from early phase clinical trials to FDA-approved products.

Despite decades of drug development and a deepening understanding of the biology of diffuse large B-cell lymphoma, physicians haven’t seen much improvement in cure rates, Thomas E. Witzig, MD, said during a presentation at the 2018 SOHO Annual Meeting.

Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, following at least 2 lines of systemic therapy.








Second-Line Therapy in Extranodal Marginal Zone Lymphoma

Tisagenlecleucel has gained approval from the European Commission as a treatment for adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.
















































