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FDA Grants Breakthrough Therapy Designation to Bemarituzumab for Select FGFR2b+/HER2- Advanced Gastric and GEJ Cancers
April 20, 2021
The FDA has granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2b overexpression or amplification.
PFS Benefit Shown With Maintenance Olaparib in BRCA1/2+ Advanced Ovarian Cancer
April 20, 2021
William H. Bradley, MD discusses the 5-year follow-up of the ongoing SOLO-1 trial, which is determining the efficacy of maintenance olaparib in patients with BRCA1/2-mutated advanced ovarian cancer.
Frailty Score, Morphologic Subtype May Indicate Surgical Outcomes in Ovarian Cancer
April 20, 2021
In an interview with Targeted Oncology, Katelyn Handley, MD, discussed two studies on ovarian cancer subtypes and the use of a frailty index to determine patient outcomes before, during, and after ovarian cancer debulking surgery.
FDA Grants Orphan Drug Status to Novel IRAK4 Inhibitor in AML and MDS
April 19, 2021
The FDA has granted an orphan drug designation to CA-4948, a first-in-class, small-molecule inhibitor of IRAK4, for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.
FDA Grants Priority Review to Enfortumab Vedotin for Urothelial Cancer
April 19, 2021
The FDA has granted priority review for 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of a subset of patients with locally advanced or metastatic urothelial cancer.
Preclinical Research Shows Potential for EZH1/2 Dual Inhibitor In Relapsed/Refractory MCL
April 19, 2021
A new report on ibrutinib-resistant mantle cell lymphoma patient-derived xenograft mouse models shows the potential benefit of the EZH1/2 inhibitor OR-S1, as other similar inhibitors have shown benefit in patients with hematologic cancers.
NCCN Guidelines for RCC Add Frontline Lenvatinib/Pembrolizumab as Preferred Treatment Option
April 17, 2021
Recent updates to the National Comprehensive Cancer Network’s guidelines for renal cell carcinoma reflect quick integration of new agents and combination regimens to provide patients with RCC with more treatment options and the most up-to-date options.
GlaxoSmithKline Discontinues Feladilimab in Clinical Trials for Metastatic HNSCC
April 16, 2021
GlaxoSmithKline plc has announced that they will stop enrolling patients in the phase 2 INDUCE-3 and INDUCE-4 trials while simultaneously ending the use of feladilimab, originally GSK3359609, for the treatment of PD-L1-positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma after the recommendation of the Independent Data Monitoring Committee.
Early Efficacy of Darovasertib +/- Binimetinib Better Than Historical Controls for Metastatic Uveal Melanoma
April 16, 2021
Darovasertib, a selective protein kinase C inhibitor, demonstrated promising response rates, survival, and reduction in tumor size as treatment of patients with metastatic uveal melanoma treatment both alone and in combination with binimetinib, according to preliminary results from a 7-armed phase 1/2 clinical trial.
FDA Lifts Partial Clinical Hold from Study of SBP-101 in Pancreatic Cancer
April 16, 2021
The 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.