Data from an early access program and the eNRGy trial evaluating zenocutuzumab have led the FDA to grant the agent breakthrough designation for patients with NRG1 fusion-positive pancreatic cancer.
July 2023 Brief
The NDA for ready-to-dilute cyclophosphamide injection has been approved by the FDA for various types of cancers.
The FDA plans to conduct a speedy review of an approval application for zolbetuximab in first-line locally advanced, unresectable, or metastatic HER2-negative, claudin18.2-positive gastric or gastroesophageal junction adenocarcinoma.
An investigation of treatment with concurrent paxalisib and whole brain radiotherapy is underway in a phase 1 clinical trial.
The partial clinical hold on the TakeAim Leukemia trial exploring emavusertib in patients with acute myeloid leukemia and myelodysplastic syndrome has been lifted.
Following positive phase 2 results from the ROSEWOOD study, BeiGene is seeking FDA approval of zanubrutinib plus obinutuzumab for select patients with relapsed/refractory follicular lymphoma.
The FDA approves of the phase 3 IOV-LUN-202 study design, which will include approximately 120 patients with post-anti-PD-1 non–small cell lung cancer to be treated with LN-145.
Gallium maltolate now has been granted an orphan drug designation for adult and pediatric patients with glioblastoma multiforme.
ADRX-0706 is the first asset using the antibody drug conjugate platform from Adcentrx Therapeutics to receive investigational new drug clearance from the FDA.
The acceptance of a new drug application for rivoceranib plus camrelizumab by the FDA is supported by data from the phase 3 CARES 310 study in patients with unresectable hepatocellular carcinoma.
Phase 3 research is underway to explore the efficacy and safety of selinexor plus ruxolitinib for the treatment of myelofibrosis in adults.
Initial data from the phase 1/2 APEX-01 trial support the FDA’s fast track designation for ARX517 in patients with metastatic castration-resistant prostate cancer.
Data from the phase 3 QuANTUM-First trial have led the FDA to approve quizartinib with or without standard chemotherapy for the treatment. of FLT3-ITD-mutant acute myeloid leukemia .
Although no safety or efficacy issues were reported in the biologics license application for denileukin diftitox for cutaneous T-cell lymphoma, a complete response letter has been issued.
FDA approval has been granted to dostarlimab in combination with chemotherapy for the treatment of patients with mismatch repair deficient and microsatellite instability-high primary advanced or recurrent endometrial cancer.