News

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.

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.

VCN-01 has been granted rare pediatric disease designation by the FDA for the treatment of retinoblastoma, a rare eye cancer.

Avutometinib plus defactinib shows promising early results in pancreatic cancer, earning an orphan drug designation from the FDA.

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 investigational mRNA therapy BNT111 plus cemiplimab showed better overall response rates compared with historical controls in patients with stage III/IV melanoma refractory to anti-PD-(L)1 therapy.

The FDA has granted expanded access to TLX101-CDx, a promising PET imaging agent for diagnosing and monitoring glioma.

Findings from the phase 3 PERSEUS study support the approval of subcutaneous daratumumab and bortezomib, lenalidomide, and dexamethasone in this patient population.

Harry Erba, MD, PhD, discusses myeloMATCH, a precision medicine umbrella trial for patients with acute myeloid leukemia or myelodysplastic syndrome.