BETA
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EP. 1: FDA Grants Priority Review to NDA of Ziftomenib in NPM1-Mutant AML
If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with an NPM1 mutation.
EP. 2: FDA Approves Darolutamide in Metastatic Castration-Sensitive Prostate Cancer
Darolutamide is now an FDA-approved treatment option alone or in combination with docetaxel for metastatic castration-sensitive prostate cancer.
EP. 3: FDA Receives Vepdegestrant NDA for ESR1-Mutated Breast Cancer
A new FDA application for vepdegestrant offers hope for advanced breast cancer patients with ESR1 mutations, showcasing promising trial results.
EP. 4: FDA Lifts Partial Clinical Hold on IFx-2.0 Phase 3 Trial for Merkel Cell Carcinoma
TuHURA Biosciences advances its phase 3 trial of IFx-2.0 for Merkel cell carcinoma, aiming to enhance immune response alongside pembrolizumab.
EP. 5: FDA Grants Priority Review for Lurbinectedin/Atezolizumab in ES-SCLC
FDA prioritizes review of lurbinectedin and atezolizumab for first-line maintenance therapy in extensive-stage small cell lung cancer, promising improved survival rates.
EP. 6: OS Therapies Seeks FDA RMAT Status for OST-HER2 in Pediatric Osteosarcoma
EP. 7: FDA Grants Fast Track Status to PHST001 in Ovarian Cancer
The FDA granted fast track designation to PHST001 for the treatment of advanced ovarian cancer.
EP. 8: FDA Grants Fast Track Designation to RAD101 for Imaging of Recurrent Brain Metastases
EP. 9: FDA Approves Taletrectinib for ROS1-Positive Non-Small Cell Lung Cancer
Taletrectinib gains FDA approval as a groundbreaking treatment for ROS1-positive non-small cell lung cancer, offering hope for patients with CNS involvement.
EP. 10: FDA Approves Zanubrutinib Tablet for All Indications
The FDA has approved a tablet version of zanubrutinib for all indications, improving convenience and reducing pill burden for patients with blood cancers.
EP. 11: FDA Approves Intravesical Mitomycin in Non–Muscle-Invasive Bladder Cancer
The FDA approved intravesical mitomycin in non–muscle-invasive bladder cancer as an nonsurgical alternative to transurethral resection of bladder tumors.
EP. 12: FDA Greenlights Perioperative Pembrolizumab in Resectable HNSCC
The FDA has granted approval to pembrolizumab for the treatment of adult patients with resectable, locally advanced HNSCC whose tumors express PD-L1 with a CPS of ≥1.
EP. 13: PHOX2B PC-CAR T Enters Human Trials Following FDA IND Approval
Myrio's PHOX2B PC-CAR T therapy gains FDA approval for human trials, promising innovative treatment for patients with high-risk neuroblastoma.
EP. 14: CID-078 Receives FDA Orphan Drug Designation in Small Cell Lung Cancer
EP. 15: FDA Approves Label Update But Not Expansion for Talazoparib/Enzalutamide in mCRPC
FDA updates talazoparib and enzalutamide labeling, confirming survival benefits for HRR-mutated mCRPC, while excluding non-HRR patients.
EP. 16: FDA Approves Tafasitamab in R/R Follicular Lymphoma
Tafasitamab-cxix gains FDA approval for relapsed follicular lymphoma, showcasing significant progression-free survival benefits in combination therapy.
EP. 17: FDA Grants Orphan Drug Designation to SENTI-202 for R/R AML
SENTI-202, a groundbreaking CAR NK-cell therapy, targets relapsed/refractory AML, offering hope for patients with limited treatment options.
EP. 18: Behind the FDA Approval: Dr Poh on Tafasitamab in FL
Christina Poh, MD, discusses the recent FDA approval of tafasitamab plus lenalidomide and rituximab in relapsed/refractory follicular lymphoma.
EP. 19: FDA Clears IND for Phase 1 Study of Lonitoclax in Relapsed/Refractory AML
FDA clears lonitoclax for a phase 1 trial in relapsed/refractory AML, promising improved safety and efficacy over existing therapies.
EP. 20: FDA Grants Accelerated Approval to Dato-DXd in Previously Treated EGFR+ NSCLC
FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated patients.
