Jordyn Sava

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.

Data from the phase 3 CAPItello-281 trial showed that capivasertib plus abiraterone and androgen deprivation therapy significantly improved radiographic progression-free survival in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.

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.

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

The phase 3 SKYSCRAPER-01 trial of tiragolumab and atezolizumab in PD-L1-high non–small cell lung cancer did not meet its primary end point of overall survival.

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.

Shubham Pant, MD, MBBS, discussed the use of zanidatamab and the HERIZON-BTC-01 trial in HER2-positive biliary tract cancer treatment.

A phase 1 trial of α-lactalbumin vaccine for the treatment of patients with triple-negative breast cancer demonstrated safety and tolerability.

Ibrahim N. Muhsen, MD, evaluated the efficacy of brexu-cel in adult patients with central nervous system involvement in relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA has accepted a supplemental new drug application for the combination of darolutamide and androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.

In an interview, Antoni Vilaseca Cabo, MD, discussed the clinical activity of TAR-210 in patients with non-muscle invasive bladder cancer.

Invikafusp alfa showed promise as a treatment option across a range of high tumor mutational burden cancers or virally associated malignancies.

Denise Yardley, MD, discussed results with ribociclib in patients with early-stage breast cancer with no lymph node involvement who were enrolled in the phase 3 NATALEE trial.

Treatment with pimicotinib achieved a 54% objective response rate at 25 weeks vs 3.2% with placebo in patients with TGCT, significantly reducing stiffness and pain.

The TROPION-Lung12 trial uses a circulating tumor DNA assay to preoperatively screen patients with non–small cell lung cancer for eligibility in post-surgical adjuvant treatment regimens.

The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination therapy and streamlining safety warnings.

Cesar Rodriguez, MD, discussed several key aspects of talquetamab use in the treatment of relapsed/refractory multiple myeloma.

The FDA granted fast track designation to ALE.P02, an antibody-drug conjugate targeting Claudin-1 (CLDN1), for use in patients with advanced/metastatic CLDN1-positive squamous solid tumors.

The phase 1 INSIGHT-003 trial showed that adding eftilagimod alpha to pembrolizumab and chemotherapy achieved a median overall survival of 32.9 months in metastatic non–small cell lung cancer.

The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for patients with metastatic non–small cell lung cancer with MET exon 14 skipping alterations eligible for tepotinib.