EP. 1: FDA Grants Priority Review to T-DXd for HR+, HER2-Low/Ultralow Breast Cancer
The application is supported by results from the phase III DESTINY-Breast06 trial.
EP. 2: Acalabrutinib Receives FDA Priority Review in Frontline MCL
Acalabrutinib, a BTK inhibitor, has shown promising results in treating mantle cell lymphoma, with the FDA granting it priority review.
EP. 3: FDA Approves Perioperative Nivolumab in Resectable NSCLC
The FDA has approved nivolumab plus chemotherapy as a neoadjuvant treatment for operable stage IIA to IIIB non–small cell lung cancer, based on data from the phase 3 CheckMate 77T trial.
EP. 4: FDA Approves Cologuard Plus Stool DNA Test for Colorectal Cancer Screening
The noninvasive test provides a beneficial screening tool for patients 45 and older at average risk for colorectal cancer.
EP. 5: VLS-1488 Gains FDA Fast Track Status in Advanced Ovarian Cancer
The FDA has granted VLS-1488 fast track designation in patients with platinum-resistant high-grade serous ovarian cancer.
EP. 6: Namodenoson Earns FDA Orphan Drug Designation in Pancreatic Cancer
The sponsor is preparing a phase 2 study to evaluate namodenoson in this patient population.
EP. 7: FDA Approves Inavolisib Plus Standard Therapy in PIK3CA-Mutant Breast Cancer
The approval of inavolisib is supported by findings from the phase 3 INAVO120 study evaluating the agent plus palbociclib and fulvestrant.
EP. 8: FDA Clears IND of Novel ADC in AML Treatment
BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid leukemia.
EP. 9: FDA Provides Positive Feedback on AMPLIFY Trial for Prostate Cancer Diagnostic
The phase 3 trial AMPLIFY study plans to test the diagnostic performance of 64Cu-SAR-bisPSMA PET/CT imaging in approximately 220 patients with prostate cancer with biochemical recurrence.
EP. 10: FDA Oks Optune Lua for Use With PD-1/PD-L1 Inhibitors in Metastatic NSCLC
Following promising results from the phase 3 LUNAR trial, the FDA has approved Optune Lua for use with PD-1/PD-L1 inhibitors or docetaxel in patients with metastatic non–small cell lung cancer.
EP. 11: FDA Clears NDA of Intravesical Mitomycin in Non–Muscle-Invasive Bladder Cancer
A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.
EP. 12: FDA Grants Rare Pediatric Disease Designation to Galinpepimut-S in AML
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.
EP. 13: LP-184 Earns FDA Fast Track Designation in Glioblastoma
The agent is currently being evaluated in a phase 1a study, and a phase 1b/2a study will continue to assess LP-184’s safety and efficacy.
EP. 14: FDA Pushes Back Decision on Sotorasib/Panitumumab in Colorectal Cancer
The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal cancer on October 17, 2024.
EP. 15: Zolbetuximab Scores FDA Approval in CLDN 18.2+ Gastric/GEJ Cancer
This approval marks the first CLDN 18.2-targeted therapy in this patient population.
EP. 16: FDA Approves Companion Diagnostic for Vorasidenib in IDH-Mutant Glioma
The FDA has approved the Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for treatment with vorasidenib.
EP. 17: FDA Accepts NDA Resubmission of Rivoceranib and Camrelizumab in HCC
The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic hepatocellular carcinoma is supported by the final survival analysis of CARES-310 trial.
EP. 18: FDA Grants Priority Review for TLX101-CDx PET Imaging Agent in Glioma
The FDA accepted the new drug application for TLX101-CDx and granted priority review to the agent in glioma.
EP. 19: FDA Fast Tracks HC-7366 in Relapsed/Refractory Acute Myeloid Leukemia
The FDA granted fast track status to HC-7366 for relapsed/refractory AML treatment.
EP. 20: FDA Expands Approval for Jylamvo Oral Methotrexate Solution in ALL
The indication for Jylamvo now includes pediatric patients with acute lymphoblastic leukemia.
EP. 21: FDA Approves Asciminib in Newly Diagnosed Ph+ CML in Chronic Phase
Asciminib has gained accelerated approval from the FDA for the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
EP. 22: Ready-to-Use 3-Month Leuprolide Depot Formulation Nears FDA Approval
A new drug application for a 3-month depot formulation of leuprolide mesylate has been submitted to the FDA.
EP. 23: FDA Issues Warning on BioZorb Markers After Recall Due to Patient Complications
Providers advised to halt use, monitor patients, and report any complications with BioZorb devices to the FDA.
EP. 24: FDA Lifts Clinical Holds Placed on 3 CAR T-cell Therapy Trials
The FDA has lifted clinical holds on trials of zevor-cel, satri-cel, and CT071, and trials will now resume in the US.
