EP. 1: FDA Unhalts Phase 1 Trial of MT-0169 in R/R Myeloma and NHL
The FDA is no longer concerned about the safety of MT-0169, and the developer of the agent plans to focus its effort on the extramedullary myeloma population.
EP. 2: FDA Lifts Partial Clinical Hold on Study of FHD-286 in R/R AML, MDS
Now that the FDA has lifted the partial clinical hold on the phase 1 study of FHD-286 in patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome, there are plans to initiate a trial to further assess the agent with decitabine or cytarabine.
EP. 3: FDA May Soon Approve Pembrolizumab Plus Standard Chemotherapy for Advanced BTC
A regular review of an FDA approval application is underway for the combination of pembrolizumab and standard chemotherapy for the treatment of advanced biliary tract cancer.
EP. 4: FoundationOne Liquid CDx Granted New FDA Indication in mCRC
The FoundationOne®Liquid CDx has received FDA approval as a companion diagnostic for encorafenib plus cetuximab for patients with BRAF V600E-mutated metastatic colorectal cancer.
EP. 5: FDA Grants Priority Review to Capivasertib/Fulvestrant for HR+ Breast Cancer
Data from the phase 3 CAPItello-291 trial of capivasertib plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer have led the FDA to grant priority review to the new drug application for the combination.
EP. 6: FDA Extends PDUFA Date for NDA of Nirogacestat for Desmoid Tumors by 3 Months
The FDA has requested additional time to assess the analyses of previously submitted data from the phase 3 DeFi trial of nirogacestat in desmoid tumors, leading to an extension of the Prescription Drug User Fee Act decision date.
EP. 7: FDA Authorizes Start to Phase 1b Trial of STAR-LLD Combo in Multiple Myeloma
A newly authorized phase 1b study will evaluate the safety and efficacy of the continuous delivery of lenalidomide among patients with multiple myeloma.
EP. 8: FDA Accepts sNDA for First-Line NALIRIFOX in Metastatic PDAC
Data from the phase 3 NAPOLI 3 trial have led the FDA to accept a supplemental new drug application for NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma
EP. 9: FDA Approves Glofitamab for Relapsed/Refractory DLBCL
Glofitimab is the first and only CD20xCD3 T-cell engaging bispecific antibody approved for the treatment of relapsed/refractory DLBCL.
EP. 10: ODAC Discusses Dose Optimization of New Drugs for Pediatric Patients With Cancer
The FDA’s Oncologic Drugs Advisory Committee discussed the potential need for interpreting pharmacology data, using trial designs that compare multiple dosages, and safety and tolerability assessments to help determine the optimal doses of oncology drugs for pediatric patients.
EP. 11: FDA Halts Phase 1 PLAT-08 Study of SC-DARIC33 in AML
Following a report of a serious grade 5 adverse event, the phase 1 PLAT-08 trial of SC-DARIC33 in pediatric patients with acute myeloid leukemia has been placed on hold
EP. 12: FDA Clears Addition of Final Analysis to Phase 3 Study of Uproleselan in AML
A time-based pathway to final analysis has been cleared by the FDA to evaluate the effect of uproleselan on relapsed/refractory acute myeloid leukemia.
EP. 13: FDA Pauses iMMagine-1 Study of CART-ddBCMA in Relapsed/Refractory Multiple Myeloma
Although dosing will continue in iMMagine-1 for patients who responded well to CART-ddBCMA, recruitment has been halted due to to a safety concern.
EP. 14: FDA Grants Approval to Talazoparib Plus Enzalutamide for HRR-Gene Altered mCRPC
On the heels of an ASCO presentation of data from the phase 3 TALAPRO-2 trial, the FDA has granted approval to the study combination for the treatment of a metastatic castration-resistant prostate cancer subgroup.
EP. 15: NDA Submitted to the FDA for Imetelstat in R/R Myelodysplastic Syndrome
Following positive data from the phase 3 IMerge study of imetelstat, the FDA has received a new drug submission for the agent for the treatment of patients with relapsed or refractory myelodysplastic syndrome.
EP. 16: Blinatumomab Now Fully Approved by FDA for MRD+ B-ALL
Additional data have led to a full FDA approval for blinatumomab.
EP. 17: KT-253 Lands FDA Orphan Drug Status for AML
The phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of KT-253 monotherapy in patients with acute myeloid leukemias.
EP. 18: FDA Denies NDA of ADX-2191 for Primary Vitreoretinal Lymphoma
ADX-2191 will not be granted approval by the FDA due to the results of the phase 3 GUARD trial.
EP. 19: FDA Orphan Drug Designation Bestowed to VCN-01 Plus Chemotherapy for Early PDAC
The phase 2b VIRAGE study will investigate the safety and efficacy of VCN-01 plus standard chemotherapy in patients with first-line pancreatic ductal adenocarcinoma.
EP. 20: FDA Grants FTD to Quaratusugene Ozeplasmid Plus Atezolizumab in ES-SCLC
A fast track designation has been granted by the FDA to quaratusugene ozeplasmid with atezolizumab for the treatment patients with extensive-stage small cell lung cancer.
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