EP. 1: FDA OKs Pembrolizumab Plus Standard Chemotherapy for Advanced BTC
The approval of pembrolizumab with gemcitabine and cisplatin offers a new immunotherapy regimen for patients with locally advanced unresectable or metastatic biliary tract cancer.
EP. 2: FDA Halts Phase 1 Trial of NX-2127 in Various B-Cell Malignancies
With a partial clinical hold in place, patient enrollment must halt in the phase 1 NX-2127-001 trial.
EP. 3: FDA Grants ODD to Rhenium Obisbemeda for Breast Cancer and Leptomeningeal Metastases
Rhenium obisbemeda shows potential to address the unmet need of new treatment options for patients with breast cancer and leptomeningeal metastases and will continue to be evaluated in the ReSPECT-LM program.
EP. 4: FDA Clears IND of Investigational Immunotherapy for NMIBC Development Program
With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.
EP. 5: FDA Grants Orphan Drug Designation to AL102 in Desmoid Tumors
Data from the phase 2 of the RINGSIDE trial have led the FDA to grant an orphan drug designation to AL102 as a potential therapeutic option for patients with desmoid tumors.
EP. 6: FDA Approves Fruquintinib for Previously Treated Metastatic Colorectal Cancer
Fruquintinib is a new, well-tolerated option for the treatment of patients with refractory metastatic colorectal cancer.
EP. 7: FDA Restricts Pembro/Chemo Use for Gastric Cancer
The updated indication limits the use of pembrolizumab and chemotherapy to tumors expressing PD-L1 as determined by an FDA-approved test.
EP. 8: FDA Accepts sBLA for Liso-Cel in Relapsed or Refractory CLL/SLL
The application for lisocabtagene maraleucel in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma has been accepted by the FDA, following positive results from the TRANSCEND CLL 004 study.
EP. 9: FDA Grants Orphan Drug Designation to THIO for Glioblastoma
THIO has received 2 prior orphan drug designations, and the agent has shown promise in preclinical studies for the treatment of glioblastoma.
EP. 10: RZ-001 Gains FDA Fast Track Designation in Glioblastoma
A phase 1/2 trial is evaluating the safety, efficacy, and tolerability of RZ-001 in patients with glioblastoma.
EP. 11: FDA OKs PD-L1 pharmDx for Gastric and GEJ Cancer
This companion diagnostic tool, which is already approved for use in 5 other cancer types, identifies patients who may be suited for treatment with pembrolizumab.
EP. 12: FDA Fast Tracks SONALA-001 Plus MR-Guided Focused Ultrasound in DIPG
The fast track designation granted to SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device from the FDA is for the treatment of patients with diffuse intrinsic pontine glioma.
EP. 13: FDA to Review ProSense De Novo Request in Early-Stage Breast Cancer
Following the FDA’s denial of a de novo classification request of ProSense, citing concerns about the choice of comparator group used in the ICE3 trial, IceCure is working to identify a more representative comparator group.
EP. 14: SIRPant-M Receives FDA Orphan Drug Designation for T-Cell Lymphoma
SIRPant-M has been granted orphan drug designation by the FDA for patients with T-cell lymphoma.
EP. 15: FDA Approves Repotrectinib in ROS1+ NSCLC
Repotrectinib is now an FDA-approved option for patients with ROS1- positive advanced non–small cell lung cancer.
EP. 16: FDA’s ODAC Confronts Issues With Accelerated Approval Program
The FDA’s Oncologic Drugs Advisory Committee discussed delays that can occur when drugs are granted accelerated approval, and the post-approval confirmatory trials of pralatrexate and belinostat for peripheral T-cell lymphoma.
EP. 17: FDA Approves Pembrolizumab/Chemo for Gastric and GEJ Adenocarcinoma
Pembrolizumab and fluoropyrimidine- and platinum-containing chemotherapy are now FDA-approved for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
EP. 18: FDA Greenlights Capivasertib/Fulvestrant in Breast Cancer With PIK3CA, AKT1, PTEN Alterations
The FDA has approved capivasertib with fulvestrant for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations.
EP. 19: FDA OKs Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer
Enzalutamide is the first and only androgen receptor signaling inhibitor approved by the FDA in this intent-to-treat population.
EP. 20: FDA to Review sBLA for Amivantamab Plus Chemo in EGFRm Advanced NSCLC
Positive findings from the MARIPOSA-2 study of amivantamab with chemotherapy with or without lazertinib in locally advanced or metastatic non–small cell lung cancer with EGFR mutations support the submission of a supplemental biologics license application to the FDA.
EP. 21: FDA Oks FoundationOne®CDx for Capivasertib/Fulvestrant in Breast Cancer
In addition to the approval of capivasertib and fulvestrant, the FDA has granted approval to the FoundationOne® CDx as a companion diagnostic to identify patients with advanced HR-positive, HER2-negative advanced breast cancer.
EP. 22: Behind the FDA Approval of Enzalutamide for Prostate Cancer
Neal Shore, MD, FACS, discussed the phase 3 EMBARK trial and what the FDA approval of enzalutamide means for the prostate cancer treatment landscape.
EP. 23: FDA Clears IND for Phase 1B Study of TCB008 in AML
An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.
EP. 24: FDA Grants Epcoritamab Breakthrough Drug Designation for FL
The FDA breakthrough drug designation for epcoritamab in follicular lymphoma was supported by findings from the phase 1/2 EPCORE NHL-1 study.
EP. 25: BLA Seeks Approval of Obe-Cel in B-ALL From the FDA
The biologics license application seeking the approval of obe-cel as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.
EP. 26: FDA Approves Nirogacestat for Patients With Desmoid Tumors
Nirogacestat is now an FDA-approved option for adult patients with progressing desmoid tumors who require systemic treatment.
EP. 27: FDA Grants FTD to Olvi-Vec in Ovarian Cancer Subgroup
Olvimulogene nanivacirepvec, an oncolytic viral-based therapy, has earned a fast track designation from the FDA in ovarian cancer resistant or refractory to platinum-based chemotherapy.
EP. 28: Zotatifin Triplet Gains FDA Fast Track Status in ER+/HER2- Breast Cancer
A fast track designation has been granted to zotatifin with fulvestrant, and abemaciclib for adult patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer.
EP. 29: FDA Clears IND for CT-0525 in Solid Tumors Overexpressing HER2
CT-0525 is an ex vivo gene-modified autologous CAR-monocyte cellular therapy being evaluated for the treatment of HER2-overexpressing solid tumors.
EP. 30: FDA Clears IND for Tumor Infiltrating Lymphocyte Therapy
A phase 1/2 study of KSQ-001EX will commence at MD Anderson Cancer Center following this investigational new drug approval from the FDA.
EP. 31: FDA Initiates Investigation of CAR T Immunotherapies
The investigation follows reports of T-cell malignancies after treatment with chimeric antigen receptor T-cell immunotherapies.
EP. 32: FDA Grants Priority Review to Enfortumab Vedotin/Pembrolizumab in mUC
Positive data from the phase 3 EV-302 trial of enfortumab vedotin with pembrolizumab in locally advanced or metastatic urothelial cancer have shifted the landscape.
EP. 33: A Look Back at the FDA News From November 2023
Here is a look back at the FDA happenings from the month of November 2023.
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