News

In an interview, Vincent Law, of Moffitt Cancer Center, discussed a new study that offers hope for patients with melanoma brain metastasis.

R289, a dual IRAK1/4 inhibitor, has received fast track status from the FDA for treating transfusion-dependent lower-risk MDS in patients with inadequate responses to prior therapies.

Susan L. Slager, PhD, discusses some of the recommendations for genetic testing in individuals with a family history of chronic lymphocytic leukemia.

The PANOVA-3 trial demonstrated a significant 2-month overall survival improvement when adding tumor treating fields to gemcitabine and nab-paclitaxel for patients with locally advanced pancreatic adenocarcinoma.

The combination of HBI-8000 and nivolumab induced a response in nearly two-thirds of patients with advanced melanoma and no prior anti–PD-1/PD-L1 treatment.

Here is a look back on all the FDA happenings from the month of November 2024.

Barbara O’Brien, MD, discusses the next steps of the phase 2 TBCRC049 study for the treatment of patients with HER2-positive breast cancer and leptomeningeal metastasis.

The FDA accepted darolutamide’s application for metastatic hormone-sensitive prostate cancer, imatinib is now in liquid form, and ribociclib, combined with an NSAI, showed significant benefit in high-risk, node-negative early-stage breast cancer. Brexu-cel demonstrated CNS remission in relapsed/refractory B-ALL, and a new vaccine shows promise in breast cancer.

Susan L. Slager, PhD, discusses the use of polygenic risk scoring to assess individual risk for CLL.

Sarah Sammons, MD, discusses some of the challenges seen with different regimens for HER2-positive metastatic breast cancer treatment

Reid Merryman, MD, discusses which patients are typically monitored for minimal residual disease and whether there are specific subtypes or stages where the assessment is particularly critical.

Domenica Lorusso, MD, PhD, discusses the rationale behind the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study.

A recent Targeted Oncology survey explores the challenges and best practices in transitioning patients with cancer from inpatient to outpatient care, featuring insights from Cristina Gasparetto, MD, on improving these processes.

LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.

Enrollment has been completed for the phase 1b/2 ASIST study that is evaluating BXQ-350 in combination with standard-of-care treatments in patients with newly diagnosed metastatic colorectal cancer.

Samer A. Al’Hadidi, MD, discusses factors influencing early use of chimeric antigen receptor T-cell therapy in patients with relapsed/refractory multiple myeloma.

Susan L. Slager, PhD, discusses the background of her research on inherited germline genetics for risk of chronic lymphocytic leukemia.

STC-15, an investigational RNA methyltransferase inhibitor, has shown promising clinical activity and an encouraging safety profile across various tumor types.

The FDA has received a biologics license application submission for RP1 plus nivolumab in patients with PD-1 inhibitor–exposed melanoma.

LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB, has received FDA orphan drug designation for neuroendocrine cancer treatment.

The FDA approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as a companion diagnostic to assess HER2+ status in patients with BTC.

Phase 1 trial findings showed that GD2-CAR T-cell therapy induced significant tumor regressions and neurological improvements in patients with H3K27M-mutant diffuse midline gliomas.

The FDA has accepted the BLA for belantamab mafodotin in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone, in relapsed/refractory multiple myeloma, as supported by DREAMM-7 and DREAMM-8 data.

Imatinib oral solution has gained FDA approval for the treatment of some cancers, including certain forms of leukemia.

Alexander J. Fife, MD, discussed the challenges of diagnosing endometrial cancer, highlighting delays in care.

Chunhui Han, PhD, discusses the potential feasibility of the integration of Gallium 68 PSMA-11 in biology-guided radiotherapy for patients with prostate cancer with bony metastases.

The FDA grants approval to revumenib (SNDX-5613) for a subgroup of acute leukemia, and dato-dXd moves into the final stage in NSCLC. We also cover expert updates from the 42nd Annual Chemotherapy Symposium Foundation in CLL, as well as other relevant insights on CML and multiple myeloma treatment.

Antoni Vilaseca Cabo, MD, discusses the rationale behind the phase 1 study evaluating the safety and efficacy of TAR-210 in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer.