HEMATOLOGY

Daratumumab (Darzalex) has been submitted for FDA approval for use in combination with bortezomib (Velcade), melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

A round-up of all the FDA activity that occurred in the month of November, including several approvals for hematologic malignancies.

The Leukemia & Lymphoma Society (LLS) has awarded Barbara Savoldo, MD, PhD, with a $600,000, 3-year grant in support of her promising research into a CAR T-cell treatment with a “safety switch” that could alleviate potential side effects for patients with acute lymphoblastic leukemia being treated with the immunotherapy.

A biologics license application for mogamulizumab has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy, Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody, has announced.

The American Society of Hematology has announced that James R. Downing, MD, of St. Jude Children’s Research Hospital will be awarded the 2017 E. Donnall Thomas Lecture and Prize for his discoveries related to the hematopathology and molecular biology of childhood leukemia.

Nilotinib (Tasigna) has been approved by the FDA for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. The approval is both in the frontline setting and for those with resistance or intolerance to prior therapy, including imatinib.

The anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy bb2121 has been granted a breakthrough therapy designation by the FDA for previously treated patients with relapsed/refractory multiple myeloma.

Obinutuzumab (Gazyva) has been approved by the FDA in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with advanced follicular lymphoma, according to Genentech, the manufacturer of the therapy.

Natalie S. Callander, MD, Professor of Medicine, University of Wisconsin Carbone Cancer Center, discusses updates in the treatment of relapsed/refractory multiple myeloma.

Adam Waxman, MD,&nbsp;discusses emerging regimens for patients with multiple myeloma.<br /> &nbsp;

Progression-free survival was extended by 3.6 months with higher-dose, once-weekly carfilzomib (Kyprolis) compared with a lower-dose, twice-weekly regimen in patients with relapsed/refractory multiple myeloma, according to&nbsp;according to phase III results from the ARROW trial.

Understanding genetic abnormalities is key to better improving outcomes in multiple myeloma, particularly for high-risk patients, Shaji K. Kumar, MD, said in his talk at the&nbsp;35th annual CFS.

Vancheswaran Gopalakrishnan, MPH, a post-doctorate fellow in Dr. Jennifer Wargo&#39;s laboratory at The University of Texas MD Anderson Cancer Center, discusses a study that explored the diversity and composition of the gut microbiome in melanoma patients and its influence on response to anti-PD-1 therapy&nbsp;during The Society for Immunotherapy of Cancer (SITC) 32nd&nbsp;Annual Meeting. Dr.&nbsp;Gopalakrishnan completed this study under the mentorship of Dr. Wargo, who was the principal investigator.&nbsp;

Owen O&#39;Connor, MD, PhD, professor of medicine and Experimental Therapeutics, director of the Center for Lymphoid Malignancies, Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, discusses the agents approved by the FDA for the treatment of mantle cell lymphoma (MCL), including acalabrutinib (Calquence) and bortezomib (Velcade).

According to results from the phase III phase III LyMa trial published in the <em>New England Journal of Medicine, </em>survival was improved for patients with mantle cell lymphoma with maintenance&nbsp;rituximab (Rituxan) following autologous stem-cell transplantation (ASCT).

Andre Goy, MD,&nbsp;discusses the excitement surrounding novel therapies on the horizon in mantle cell lymphoma, as well as how the treatment paradigm will shift in the next 5 to 10 years.

Over the past few years, remarkable advances have been achieved in the field of CLL by rationally targeting pathways overexpressed and used by the malignant clone for proliferation and survival. These developments have been achieved by a better understanding of the underlying biology and the disease process.

Checkpoint-based immune therapies have revolutionized the therapy of solid tumors by achieving breakthrough improvements in melanoma, lung cancer, renal cancer, bladder cancers, and head and neck tumors, among others.

Ruben Mesa, MD, director, UT Health San Antonio Cancer Center, discusses NCCN guideline updates in polycythemia vera and essential thrombocythemia.

Vemurafenib (Zelboraf) has been granted approval by the FDA&nbsp;as a treatment for patients with <em>BRAF</em> V600-mutated Erdheim-Chester disease (ECD). This is the first approved therapy for this rare blood disorder.

Brentuximab vedotin&nbsp;(Adcetris) has been submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine for the frontline treatment of patients with&nbsp;advanced classical Hodgkin lymphoma.&nbsp;Seattle Genetics,&nbsp;the company developing brentuximab vedotin, recently announced the submission of a&nbsp;supplemental new drug application for the&nbsp;CD30-targeted antibody-drug conjugate.

The B-cell maturation antigen antibody-drug conjugate&nbsp;GSK2857916 has been granted a breakthrough therapy designation by the FDA for the treatment of patients with relapsed/refractory multiple myeloma,&nbsp;GlaxoSmithKline has announced.

Sandy Wong, MD, assistant professor, Division of Hematology/Oncology, UCSF School of Medicine, discusses the progress that has been made with monocloncal antibodies for the treatment of plasma cell neoplasms.

Richard M. Stone, MD, director of the Adult Leukemia Program, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School, discusses monitoring minimal residual disease (MRD) in patients with acute myeloid leukemia (AML).

Shaji K. Kumar, MD, professor of medicine, Mayo Clinic, discusses the management of newly diagnosed patients with multiple myeloma.