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FDA Lifts Partial Clinical Hold from Study of SBP-101 in Pancreatic Cancer
April 16th 2021The FDA has lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.
FDA Approves Nivolumab Plus Chemotherapy as 1L Therapy for Advanced or Metastatic Gastric Cancer
April 16th 2021The FDA has approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Phase 3 Study of Imtelstat Versus BAT Explores Survival Improvement in Myelofibrosis
April 15th 2021A phase 3 study with the goal of demonstrating overall survival benefit with imetelstat versus best available therapy in patients with refractory myelofibrosis has dosed the first patient with the experimental agent.
Phase 3 Study Supports Pembrolizumab in Treatment of Relapsed/Refractory Classical Hodgkin Lymphoma
April 14th 2021The interim analysis from the phase 3 KEYNOTE-204 study suggests pembrolizumab should be considered the preferred treatment option for patients with relapsed or refractory classical Hodgkin lymphoma over brentuximab vedotin.
FDA Accelerates Approval of Sacituzumab Govitecan in Locally Advanced or Metastatic UC
April 13th 2021An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
CYNK-001 Granted Orphan Drug Designation for Treatment of Malignant Gliomas
April 13th 2021The FDA has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.
Telisotuzumab Vedotin Shows Promising Efficacy and Safety Results for c-Met+ NSCLC
April 13th 2021Telisotuzumab vedotin monotherapy demonstrated a promising objective response rate and has a tolerable safety profile in patients with previously treated c-Met–positive advanced non–small cell lung cancer, according to findings from a phase 2 trial presented in a poster at the American Association for Cancer Research Annual Meeting 2021.
Gedatolisib Plus Palbociclib Shows Promise in Treating ER+/HER2- Advanced Breast Cancer
April 12th 2021Gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus palbociclib and endocrine therapy demonstrated tolerability and preliminary efficacy in patients with ER+/HER2- advanced or metastatic breast cancer.
Undetectable METex14 After Savolitinib Correlates With Positive Outcomes in NSCLC
April 12th 2021After treatment with savolitinib, undetectability of MET Exon 14 in the circulating tumor DNA of patients with non‒small cell lung cancer was found to be associated with prolonged progression-free survival, and overall survival.
Parsaclisib Added to Ruxolitinib Improves Spleen Size and Symptom Burden in Myelofibrosis
April 11th 2021The addition of parsaclisib to ruxolitinib led to improvement in spleen volume reduction and symptom burden in patients with myelofibrosis who had a suboptimal response on a standard dose of ruxolitinib alone, according to results from a phase 2 study.
FDA Has Granted Priority Review to Tisotumab Vedotin for Advanced Cervical Cancer
April 10th 2021The FDA has accepted a biologics license application and granted it a priority review for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Prognostic Biomarkers for Venetoclax and Hypomethylating Agents Therapy for AML
April 9th 2021Danielle Hammond, MD, discusses prognostic factors indicating therapy success for patients with acute myeloid leukemia treated with a combination of venetoclax (Venclexta) and either decitabine or azacitadine.
Implementation of Earlier Diagnoses and Testing May Maximize Survival Outcomes for EGFR+ NSCLC
April 9th 2021According to a retrospective analysis presented during the 2021 European Lung Cancer Congress, earlier diagnosis and biomarker testing should be more widely implemented to identify patients with EGFR-positive non–small lung cancer who may benefit for EGFR inhibition.
Nivolumab-Containing Regimens Found More Effective Than Single-Agent Chemotherapy in ESCC
April 8th 2021Both the combination of nivolumab and chemotherapy and nivolumab plus ipilimumab showed a statistically significant and clinically meaningful survival benefit over chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression.
Adjuvant Pembrolizumab Prolongs Disease-Free Survival in Renal Cell Carcinoma
April 8th 2021Treatment with pembrolizumab led to improvement in disease-free survival in patients with renal cell carcinoma following nephrectomy or following nephrectomy and resection of metastatic lesions, meeting the primary end point of the pivotal phase 3 KEYNOTE-564 trial.