MULTIPLE MYELOMA

A clinical hold has been placed on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab trials and the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial has been ordered by the FDA.

A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses a first in-human multicenter study of bb2121 anti-BCMA CAR T-cell therapy for relapsed/refractory multiple myeloma.

According to findings from a small phase I study, all patients with multiple myeloma showed a response following treatment with an active dose of bb2121, an investigational anti–B-cell maturation antigen chimeric antigen receptor T-cell construct.

Patients with newly-diagnosed multiple myeloma who did not elect to undergo stem cell transplant but remained on single agent ixazomib maintenance fared as well as those who received SCT.

A supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma has been accepted by the FDA.

Daratumumab has been approved by the FDA for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.

Andrzej Jakubowiak, MD, PhD, professor of Medicine, University of Chicago Medicine, discusses safety results from an open label, phase 1b trial  exploring daratumumab (Darzalex) combined with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone in patients with newly diagnosed multiple myeloma.

Merck has announced that enrollment for the phase III KEYNOTE-183 and KEYNOTE-185 multiple myeloma trials has been postponed due to deaths in patients treated with pembrolizumab.

An overview of emerging targeted therapies and immunotherapies in chronic lymphocytic leukemia.

Sagar Lonial, MD, professor and chair, Department of Hematology & Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses recent advancements in the treatment paradigm for multiple myeloma.

Treatment with chimeric antigen receptor (CAR) T cells that target B-cell maturation protein (BMCA) achieved clinical remissions in 33 out of 35 patients (94%) with relapsed or refractory multiple myeloma in early results from a Chinese study presented at the 2017 ASCO Annual Meeting.

NYU Langone’s Perlmutter Cancer Center (PCC) has announced that Ahmad Samer Al-Homsi, MD, MBA, will lead a new bone marrow transplantation program at the center for treating blood-borne cancers, including leukemia, lymphoma, and multiple myeloma.

An overview of FDA news that happened in April.

Daratumumab has been approved by the European Commission for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of patients with multiple myeloma following at least 1 prior therapy.

Consolidation therapy with lenalidomide, bortezomib, and dexamethasone (RVD) extended progression-free survival in patients with multiple myeloma when used in conjunction with stem cell transplantation compared with RVD alone

John A. Snowden, MD, discusses guidelines that offer recommendations for screening and management of myeloma.

FDA approval is being sought for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

An investigational anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy demonstrated an objective response rate of 78% in patients with relapsed/refractory multiple myeloma.

Clinical trials of selinexor, which is being explored in several tumor types, have been placed on clinical hold by the FDA.

Lenalidomide has been approved by the FDA as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant.

Multiple myeloma expert Kenneth C. Anderson, MD, will serve as president of the American Society of Hematology through the end of this year.

Based on data from 2 phase III trials, the EMA’s CHMP has recommended approval of lenalidomide as a maintenance therapy following autologous stem cell transplant for patients with newly diagnosed multiple myeloma.

Saad Z. Usmani, MD, discusses the POLLUX update and PAVO findings presented at ASH, as well as the latest developments with daratumumab.

Monoclonal Antibodies in Relapsed Multiple Myeloma with Ola Landgren, MD, PhD

Monoclonal Antibodies in Relapsed Multiple Myeloma with Ola Landgren, MD, PhD