Jordyn Sava

Real-world data suggest optimal CLL/SLL treatment sequencing involves targeted therapies, including covalent BTKis and BCL2 inhibitors, for better survival outcomes.

An exploratory analysis of the KEYNOTE-522 study presented at the 2024 San Antonio Breast Cancer Symposium highlights predictive biomarkers for improved triple-negative breast cancer outcomes.

In an interview, Palak Dave discussed how artificial intelligence, using deep learning to analyze bone marrow aspirate smear images, could standardize and accelerate the diagnosis of MDS vs pre-MDS conditions.

Cilta-cel improved minimal residual disease negativity in lenalidomide-refractory multiple myeloma vs standard care, per CARTITUDE-4 results.

A phase 3 trial of uproleselan in relapsed/refractory acute myeloid leukemia failed to meet the primary overall survival end point but showed a benefit in primary refractory patients.

Zanidatamab is now a category 2A treatment for HER2-positive biliary tract cancer in the NCCN guidelines, following its FDA approval.

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

In an interview with Targeted OncologyT, Rupesh Kotecha, MD, discussed a study focused on how systemic therapy selection impacts outcomes in patients with brain metastases, particularly those with lung cancer.

The FDA has accepted an sBLA for glofitamab plus gemcitabine and oxaliplatin in relapsed/refractory diffuse large B-cell lymphoma.

CRB-701 has gained FDA fast track status for the treatment of adult patients with relapsed/refractory metastatic cervical cancer.

With this approval, zenocutuzumab is the first FDA-approved therapy for patients with NRG1 fusion tumors.

The FDA granted breakthrough therapy status to sacituzumab tirumotecan in EGFR-mutated advanced non–small cell lung cancer.

Sonodynamic therapy doubled the median overall survival to 15.7 months and tripled progression-free survival to 5.5 months in recurrent gliomas, according to a phase 1/2 trial.

Enrollment in cohort 5 of the phase 1/2 GOBLET study will resume after the Data Safety Monitoring Board’s safety review.

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the CEPHEUS trial results and impact on frontline treatment in transplant-ineligible patients with newly diagnosed multiple myeloma.

TERN-701 showed promising early results, with significant molecular responses and a strong safety profile in heavily pre-treated patients with chronic myeloid leukemia.

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.

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.