All Oncology News

The FDA has told AstraZeneca and MSD that the agency will extend the Prescription Drug User Fee Act date by 3 months to provide further time for a full review of the supplementary new drug application for olaparib plus abiraterone and prednisone or prednisolone for patients with mCRPC.

Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.

Joshua Brody, MD, discusses unmet needs in patient subgroups within Hodgkin lymphoma, recent advancements in the use of antibody-drug conjugates such as brentuximab vedotin and anti–PD-1 therapies in earlier lines of therapy, and future avenues for expanding the use of immunotherapy in this tumor type.

Anthony Mato, MD, MSCE, discusses the relapsed refractory setting compared with the frontline setting and promising agents such as pirtobrutinib and zanubrutinib.

The oral selective estrogen receptor degrader elacestrant has shown promise over standard second-line treatment, such as fulvestrant, for patients with metastatic hormone receptor–positive breast cancer.

A new clinical tool developed by a team of researchers led by the Dana-Farber Cancer Institute pinpoints which clonal hematopoiesis patients are at highest risk for cancer progression.

DZD1516, a reversible and selective HER2 TKI with full blood–brain barrier penetration led to tumor responses, including in patients with baseline central nervous system metastases, in a phase 1 study of patients with metastatic HER2-positive breast cancer.

Low platelet counts were associated with a greater severity of disease-related symptoms compared with low hemoglobin in patients with myelofibrosis, according to findings from a retrospective analysis of the phase 3 PERSIST-1 and PAC203 trials.

Elias Jabbour, MD, discusses the current and emerging roles of CAR T-cell therapy in B-ALL, emphasizes the importance of testing patients for MRD when determining CAR T-cell treatment strategies, and highlights how obe-cel, with its favorable safety profile, may address unmet needs related to CAR T-cell toxicities.

The Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, Arizona, is attempting to change the way preclinical studies are developed and conducted to assess the efficacy of drugs for glioblastoma multiforme.

Olutasidenib monotherapy induced high complete response rates with a manageable toxicity profile in patients with relapsed/refractory acute myeloid leukemia harboring IDH1 mutations.

The FDA has issued an accelerated approval for the Agilent Resolution ctDx FIRST assay for plasma as a companion diagnostic for adagrasib.

The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

BGB-11417, when given alone or in combination with zanubrutinib, elicited encouraging responses and minimal residual disease negativity rates in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, according to preliminary data from a phase 1 trial.

Consolidation therapy with high-dose chemotherapy and autologous stem cell transplantation improved progression-free survival vs non-myeloablative chemoimmunotherapy in patients with primary central nervous system lymphoma.

Among patients with newly diagnosed high-risk multiple myeloma, treatment with BCMA/CD19 dual-targeting FasTCAR-T Cells resulted in an overall response rate of 100%, with all treated patients evaluable for minimal residual disease showing minimal residual disease negativity to 12 months.

Administration of cyclophosphamide, tacrolimus, and mycophenolate mofetil improved 1-year GVHD relapse-free survival compared with tacrolimus plus methotrexate in patients with hematologic malignancies undergoing reduced intensity conditioning allogeneic hematopoietic cell transplantation.

The CAR-T cell therapy ciltacabtagene autoleucel has expanded options for adult patients with relapsed/refractory multiple myeloma after 4 or more lines of prior therapy in the United States, and has continued to display promising efficacy in patients with multiple myeloma following early relapse.

The FDA has accepted a new drug application for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, a radiopharmaceutical approved for imaging of neuroendocrine tumors using positron emission tomography.

Olverembatinib elicited encouraging responses and tolerability in US patients with ponatinib-resistant chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia, and in patients with CML whose tumors have a T315I mutation.

Treatment with zanubrutinib (Brukinsa) reduced the risk of progression or death by 35% compared with ibrutinib (Imbruvica) for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Blinatumomab followed by consolidation chemotherapy led to a 58% reduction in the risk of death compared with standard consolidation chemotherapy alone in adult patients with newly diagnosed minimal residual disease–negative B-cell acute lymphoblastic leukemia.

Birtamimab demonstrated a significant survival benefit in patients with Mayo Stage IV amyloid light chain amyloidosis at month 9.

The FDA has granted accelerated approval to adagrasib (Krazati) for the treatment of adult patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, who have received at least 1 prior systemic therapy.

The use of frontline ibrutinib was associated with a longer time to next treatment compared with acalabrutinib in patients with chronic lymphocytic leukemia.

Single-agent belantamab mafodotin continued to produce rapid, deep, and durable responses in patients with relapsed/refractory multiple myeloma.

Updated results from the ongoing phase 2 BGB-3111-215 trial showed that zanubrutinib provided clinically meaningful benefit to a large majority of efficacy-evaluable patients with B-cell malignancies who were intolerant to acalabrutinib.

Momelotinib elicited durable symptom, transfusion independence, and splenic responses through 48 weeks of treatment in patients with myelofibrosis who have anemia and previously received a JAK inhibitor.

The combination of belantamab mafodotin, pomalidomide, and dexamethasone elicited encouraging responses and survival benefits in patients with triple class–exposed or refractory multiple myeloma.

In this episode, OncLive® speaks with Dr. Noopur Raje on developments in multiple myeloma, Dr. Ryotaro Nakamura on data related to graft-vs-host disease, and Dr. Joshua Brody on the latest in non-Hodgkin lymphoma.