EP. 1: FDA Grants Breakthrough Designation to Zenocutuzumab for NRG1+ Pancreatic Cancer
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.
EP. 2: FDA Approves NDA of Cyclophosphamide Injection for Various Cancers
The NDA for ready-to-dilute cyclophosphamide injection has been approved by the FDA for various types of cancers.
EP. 3: FDA Grants Priority Review to BLA for Zolbetuximab in Advanced, HER2-, CLDN18.2+ Gastric/GEJ Cancer
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.
EP. 4: FDA Awards Fast Track Designation to Paxalisib With Radiation for Brain Metastases
An investigation of treatment with concurrent paxalisib and whole brain radiotherapy is underway in a phase 1 clinical trial.
EP. 5: FDA Removes Partial Clinical Hold on TakeAim Leukemia Trial of Emavusertib
The partial clinical hold on the TakeAim Leukemia trial exploring emavusertib in patients with acute myeloid leukemia and myelodysplastic syndrome has been lifted.
EP. 6: FDA Accepts sNDA for Zanubrutinib Plus Obinutuzumab for R/R Follicular Lymphoma
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.
EP. 7: FDA Says Accelerated Approval is Probable for LN-145 in NSCLC
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.
EP. 8: Gallium Maltolate Gains FDA ODD for Pediatric GBM
Gallium maltolate now has been granted an orphan drug designation for adult and pediatric patients with glioblastoma multiforme.
EP. 9: FDA Clears IND of ADRX-0706 for Select Advanced Solid Tumors
ADRX-0706 is the first asset using the antibody drug conjugate platform from Adcentrx Therapeutics to receive investigational new drug clearance from the FDA.
EP. 10: FDA Accepts NDA for Rivoceranib Plus Camrelizumab in Unresectable HCC
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.
EP. 11: FDA Grants Fast Track Designation to Selinexor for Myelofibrosis Treatment
Phase 3 research is underway to explore the efficacy and safety of selinexor plus ruxolitinib for the treatment of myelofibrosis in adults.
EP. 12: FDA Grants Fast Track Designation to ARX517 for mCRPC
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.
EP. 13: FDA Approves Quizartinib Plus Chemotherapy for Newly-Diagnosed FLT3-ITD+ AML
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 .
EP. 14: FDA Issues Complete Response Letter to BLA of Denileukin Diftitox for CTCL
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.
EP. 15: FDA Approves Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced Endometrial Cancer
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.
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