What Should Nurses Know: Gemcitabine Intravesical System’s Approval
When treating patients with bladder cancer using gemcitabine intravesical system, regular AE monitoring is necessary, said Gary Steinberg, MD.
FDA Accepts Relacorilant NDA for Platinum-Resistant Ovarian Cancer
Relicorilant’s new drug application for platinum-resistant ovarian cancer has been accepted by the FDA.
Gemcitabine Intravesical System Receives FDA OK for NMIBC
Formerly known as TAR-200, gemcitabine intravesical system has received the FDA’s approval for use in patients with BCG-unresponsive NMIBC.
Zongertinib Nabs FDA Approval in Nonsquamous HER2 TKD+ NSCLC
FDA accelerated approval was given to zongertinib for the treatment of patients with unresectable/metastatic nonsquamous NSCLC with HER2 TKD activating mutations.
FDA Grants Accelerated Approval to Dordaviprone for H3 K27M-Mutated Diffuse Glioma
The FDA has granted accelerated approval to dordaviprone for use in adult and pediatric patients with H3 K27M-mutated diffuse midline glioma.
Generic Ibrutinib Tablet Given Tentative FDA Approval in CLL/SLL, WM
A generic version of ibrutinib was granted tentative approval by the FDA for use in CLL and SLL with 17p deletion and Waldenström macroglobulinemia.
TAR-200 Granted Priority Review for Non–Muscle-Invasive Bladder Cancer
Based on durable response data, TAR-200 has been given priority review for the treatment of patients with high-risk non–muscle-invasive bladder cancer.
FDA Approves SIR-Spheres Y-90 Resin Microspheres for Unresectable HCC
The selective internal radiation therapy SIR-Spheres has been approved by the FDA for use in patients with unresectable hepatocellular carcinoma.
Sunvozertinib Granted FDA Accelerated Approval in EGFR Exon 20+ NSCLC
Sunvozertinib has received accelerated approval for use in advanced or metastatic non–small lung cancer harboring EGFR exon 20 insertion mutations.
Linvoseltamab Gains FDA Accelerated Approval In R/R Myeloma
The FDA has given accelerated approval to the BiTE, linvoseltamab, for use in the fifth line of therapy for relapsed/refractory multiple myeloma.
Oncology Drugs Approved by the FDA in June
Oncologic therapies approved in June included indications in genitourinary, lung, hematologic, and head and neck cancers.
FDA Relaxes REMS, Monitoring Rules for Liso-Cel and Ide-Cel
The FDA removed REMS and reduced certain monitoring needs for liso-cel and ide-cel in B-cell malignancies.
Ga-68 Kit Approved for Pre-Taxane RLT Selection in mCRPC
Illuccix, a preparation kit for injectable Ga-68, has been approved to select patients for radioligand therapy before taxane chemotherapy.
Dato-DXd Greenlit by FDA for Previously Treated EGFR-Mutated NSCLC
Dato-DXd was granted accelerated approval for use in adults with EGFR-mutated NSCLC after EGFR-targeted therapy and platinum-based chemotherapy.
Subcutaneous Daratumumab Could Mark First Smoldering Myeloma Treatment
Per ODAC and CHMP recommendations, subcutaneous daratumumab may become the first approved treatment for smoldering myeloma. Here’s what nurses should know.
FDA Approves Tafasitamab Combo for R/R Follicular Lymphoma
The FDA has approved tafasitamab in combination with lenalidomide and rituximab for adults with relapsed/refractory follicular lymphoma.
FDA Approves Perioperative Pembrolizumab in Head and Neck SCC
The FDA approved a perioperative pembrolizumab regimen in head and neck squamous cell carcinoma, marking the first approval in this cancer type in 6 years.
Zanubrutinib Tablets Greenlit by FDA for All Approved Indications
An oral tablet formulation of zanubrutinib was approved for use in patients with certain lymphomas or leukemia and Waldenström macroglobulinemia.
FDA Approves Mitomycin Intravesical Solution in Low-Grade NMIBC
UGN-102 has received FDA approval for use in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer.
Taletrectinib Approved by FDA for ROS1+ Non-Small Cell Lung Cancer
The tyrosine kinase inhibitor taletrectinib has been approved for use in patients with ROS1-positive non-small cell lung cancer.
May FDA Approvals in Oncology: Firsts in PPGL, Anal Cancer, and More
The FDA approved the first oral treatments for paraganglioma, pheochromocytoma, and anal cancer in May.
Darolutamide Receives FDA Approval for mCSPC
The FDA approved darolutamide monotherapy for use in metastatic hormone-sensitive prostate cancer following ARANOTE findings.
Novel ADC Receives FDA Fast Track Designation for Pancreatic Cancer
The novel antibody-drug conjugate EBC-129 has been fast tracked by the FDA for approval in pancreatic ductal adenocarcinoma.
Sevabertinib Given FDA Priority Review for HER2+ NSCLC
The oral TKI sevabertinib has been granted priority review for use in patients harboring HER2 mutations in non-small cell lung cancer.
Retifanlimab Receives FDA Approval for Advanced Anal Cancer
Retifanlimab has received approval for the frontline treatment of advanced anal cancer from the FDA.
Telisotuzumab Vedotin-tllv Given Accelerated Approval for NSCLC
Telisotuzumab vedotin-tllv has earned accelerated approval for use in patients with non-squamous non-small cell lung cancer with high c-Met overexpression.
Belzutifan Granted FDA Approval for Pheochromocytoma or Paraganglioma
Belzutifan has become the first FDA-approved oral therapy for pheochromocytoma or paraganglioma.
Fast Track Status Given to ADRX-0706 for Squamous Cell Cervical Cancer
ADRX-0706 has received FDA fast track designation for the treatment of metastatic or locally advanced squamous cell cervical cancer.
Fast Track Status Given to Givinostat for Polycythemia Vera
The safety and efficacy of givinostat is being assessed vs hydroxyurea in the phase 3 GIV-IN PV trial.
Avutometinib/Defactinib Earns FDA Accelerated Approval for KRAS+ LGSOC
The FDA has granted accelerated approval to avutometinib and defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer.
Mosunetuzumab/Polatuzumab Vedotin Triples PFS in LBCL
Nurses Lead Toxicity Monitoring in Indolent Lymphoma Care
Osimertinib/Chemo Boosts Survival in Frontline EGFR+ NSCLC
Lutetium Lu 177 Dotatate Brings Partial Response in Metastatic BP-NETs
