Jordyn Sava

In an interview with Targeted Oncology, John Mascarenhas, MD, discussed the lead up to the SENTRY trial and its potential impact on the treatment of myelofibrosis.

The FDA has granted 510(k) clearance to the SeCore™ CDx HLA A sequencing system as companion diagnostic for afamitresgene autoleucel in synovial sarcoma, paving the way for a first-of-its-kind solid tumor therapy.

In an interview, Timothy F. Cloughesy, MD, discussed the recent approval of vorasidenib in IDH-mutant gliomas and data from the phase 3 INDIGO trial.

In an interview with Targeted Oncology, Richard Lee, MD, discussed what integrative oncology encompasses and its significance in modern cancer care.

The FDA has granted approval to vorasidenib for the treatment of patients with IDH-mutant diffuse glioma.

A phase 1 trial is evaluating treatment with MT-303 in patients with hepatocellular carcinoma to determine its safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.

The FDA has rejected the SIERRA study data for Iomab-B’s biologics license application filing due to insufficient evidence of overall survival improvement.

The FDA has granted PGDx elio plasma focus Dx, the first kitted pan-solid tumor liquid biopsy test for accurate tumor mutation profiling from a blood draw, a de novo marketing authorization.

The American Society of Clinical Oncology outlines 4 key recommendations to improve access to cancer clinical trials by incorporating decentralization elements, simplifying regulatory requirements, and reducing administrative burdens.

In an interview with Targeted Oncology, Sandra P. D'Angelo, MD, discussed the approval and supporting data of afamitresgene autoleucel for the treatment of synovial sarcoma.

Harry Erba, MD, PhD, provided his insights into the groundbreaking myeloMATCH trial and its influence on the treatment of acute myeloid leukemia and myelodysplastic syndromes.

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

Afamitresgene autoleucel is now an FDA-approved treatment for patients with advanced synovial sarcoma.

The ASPEN-06 trial found that adding evorpacept to trastuzumab, ramucirumab, and paclitaxel significantly improved overall response rates and duration of response in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer.

Mayuko Sakae, MD, discussed research on pain management for patients undergoing bone marrow transplants, highlighting the potential buprenorphine shows in offering a valuable alternative to traditional opioids.

In this episode of Emerging Experts, Yu Fujiwara, MD, shares his journey from Japan to the United States and his path to becoming a specialist in hematology and oncology.

The investigational new drug application for UB-VV111, potentially the first in situ generated CD19 CAR T-cell therapy, has been cleared by the FDA, and a phase 1 trial in hematologic malignancies will begin.

The FDA has extended the PDUFA target action date for the new drug application of revumenib for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia to December 26, 2024.

The NCCN has updated its guidelines to recommend imetelstat as a top treatment for symptomatic anemia in lower-risk MDS, following its FDA approval based on encouraging phase 3 trial results.

SenoVax, a novel senolytic immunotherapy for NSCLC, has been submitted as an investigational new drug application to the FDA, initiating a clinical trial to test its efficacy.

The FDA’s Oncologic Drugs Advisory Committee convened to assess the need for rigorous trial designs evaluating perioperative regimens in resectable non–small cell lung cancer.

The first pretreated patient with HER2-altered non–small cell lung cancer was dosed with NVL-330, a novel HER2-selective inhibitor, in the HEROEX-1 trial.

The FDA has granted a fast track designation to ozuriftamab vedotin for treating recurrent/metastatic head and neck cancer that progressed after prior therapies.

TLX007-CDx, if approved by the FDA, has the potential to become a new PSMA PET imaging agent for prostate cancer.

The FDA has approved an individual patient investigational new drug application, allowing for a second dose of a novel CAR T-cell therapy for a patient with recurrent ovarian cancer.

Small cell lung cancer poses a significant challenge across the world, particularly in low-middle-income countries where it is often associated with poor outcomes.

Agenus was advised by the FDA against filing for accelerated approval of botensilimab plus balstilimab for relapsed/refractory microsatellite stable metastatic colorectal cancer without liver metastases.

As the clinical utility of ctDNA continues to be assessed, it is becoming a valuable tool for various cancer types, including gastrointestinal cancers, blood cancers, and other solid tumors.

The primary end point of increasing progression-free survival was not met in the TiNivo-2 trial in patients with advanced metastatic renal cell carcinoma.

A phase 1 trial is underway to assess the safety and efficacy of BTX-9341, a novel investigational oral degrader of CDK4/6 in HR-positive/HER2-negative breast cancer.