HEMATOLOGY

The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive.

Obinutuzumab (Gazyvaro, EU; Gazyva, US) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses the mechanism of action of selinexor for the treatment of multiple myeloma.

The Oncologic Drugs Advisory Committee voted 10-0 today to recommend approval of a biologics license application for tisagenlecleucel for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia.

A supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia has been accepted by the FDA.

In a 6-1 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approving gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia.

Blinatumomab (Blincyto) has been granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, regardless of Philadelphia chromosome status.

Jeff Sharman, MD, discusses findings of the phase III GENUINE study, which explored the combination of ublituximab (TG-1101) and ibrutinib (Imbruvica) for patients with previously treated high-risk chronic lymphocytic leukemia (CLL).

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.

ClearLLab multicolor reagents (T1, T2, B1, B2, M) has been approved by the FDA for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.

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.

The combination regimen of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab achieved a high rate of minimal residual disease-negative status in bone marrow as a first-line treatment in patients with <em>IGHV</em>-mutated chronic lymphocytic leukemia

Subcutaneous rituximab has been approved by the FDA for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated CLL.

The BTK inhibitor ibrutinib continued to demonstrate sustained progression-free survival and overall survival in chronic lymphocytic leukemia, regardless of patients&rsquo; high-risk cytogenetic status.

The combination of the anti-CD20 monoclonal antibody obinutuzumab and bendamustine induced high rates of complete response and minimal residual disease negativity with no unexpected safety signals as a first-line therapy for patients with chronic lymphocytic leukemia.

Ruben A. Mesa, MD, has been named director of the UT Health Cancer Center.

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.

Javier Pinilla-Ibarz, MD, PhD, associate member, Malignant Hematology and Immunology Program at the H. Lee Moffitt Cancer Center, discusses ongoing research with ibrutinib (Imbruvica) in chronic lymphocytic leukemia.&nbsp;

Andrzej Jakubowiak, MD, PhD, professor of Medicine, University of Chicago Medicine, discusses safety results from an open label, phase 1b trial &nbsp;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.