News

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.

The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.

Rohan Garje, MD, provides an overview of a study evaluating how mutations, including TP53, RB1, and PTEN, impact overall survival in patients with metastatic prostate cancer.

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.

LP-300, a novel small molecule, shows promise as a potential breakthrough treatment for advanced non–small cell lung cancer in never smokers.

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

Timothy F. Cloughesy, MD, discusses the impact and significance of the FDA’s approval of vorasidenib, a first-in-class option for the treatment of patients with IDH-mutant gliomas.

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

Douglas Tremblay, MD, discusses the different cytoreduction approaches available to patients with myeloproliferative neoplasms and their safety profiles.

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

Gedeptin, a novel gene therapy, is entering phase 2 clinical trials to evaluate its efficacy in treating recurrent head and neck cancer.

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

Yannis K. Valtis, MD, provides background on a single-institution, retrospective cohort study which assessed laboratory and clinical tumor lysis syndrome in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

While sacituzumab govitecan did not statistically improve overall survival vs docetaxel, there was a numerical improvement observed in patients with non–small cell lung cancer.

The FDA has granted an orphan drug designation to alemtuzumab, a chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.

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.

IMMN-001 significantly extended overall survival in patients with advanced ovarian cancer when combined with standard chemotherapy, according to phase 2 trial results.

The FDA’s ODAC mandates phase assessments for NSCLC trials, dendritic cell immunotherapy shows improved survival in pancreatic cancer, and a new blood test for colorectal cancer receives FDA approval. In addition, pembrolizumab plus neoadjuvant chemo proves effective in unresectable HGSC and THIO-cemiplimab combo shows lower toxicity in advanced NSCLC.

The phase 3 IDeate-Lung02 study has dosed its first patient with small cell lung cancer with the investigational antibody-drug conjugate infinatamab deruxtecan.

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.

Edwin Choy, MD, PhD, discusses the mechanism of action of afamitresgene autoleucel and the recent accelerated approval from the FDA for patients with advanced synovial sarcoma.

The Precision Promise and LAPIS studies failed to meet their primary end points of overall survival among patients with pancreatic cancer treated with the investigational agent pamrevlumab.

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.

Dostarlimab plus chemotherapy has been approved for the treatment of all forms of advanced endometrial cancer, including mismatch repair-deficient and microsatellite stable tumors.

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.