Here is a look back at the FDA happenings from the month of November 2020.
During the month of November 2020, the FDA granted approval to a liquid biopsy assay as a companion diagnostic for a PARP inhibitor in prostate cancer, as well as a new treatment option for patients with relapsed/refractory high-risk neuroblastoma, an option for patients with triple-negative breast cancer, and an additional dosing option for an approved treatment in non–small cell lung cancer.
In other news, the FDA also granted 4 Fast Track designations, 1 Breakthrough Therapy designation, 1 Priority Review designation, and lifted 2 partial clinical holds.
FDA Lifts Partial Clinical Hold on CAR T Cell Trial in Metastatic Castration-Resistant Prostate Cancer
The FDA lifted a partial clinical hold on November 2, 2020, on the phase 1 P-PSMA-101-001 clinical trial of the chimeric antigen receptor (CAR) T product P-PSMA-101, which is a potential treatment for patients with metastatic castration-resistant prostate cancer.
FoundationOne Liquid CDx Receives Expanded FDA Indication in Metastatic Castration-Resistant Prostate Cancer
On November 9, 2020, the FDA expanded approval of FoundationOne® Liquid CDx as a companion diagnostic for olaparib (Lynparza), which is currently indicated for use as treatment in patients with BRCA1/2 and/or ATM alterations in metastatic castration-resistant prostate cancer.
FDA Grants Fast Track Designation to CPI-613 in Metastatic Pancreatic Cancer
The FDA was granted a Fast Track designation to devimistat (CPI-613) for the treatment of metastatic pancreatic cancer on November 10, 2020.
Application for Subcutaneous Daratumumab Regimen Submitted to FDA, EMA Seeking Approval in R/R Myeloma
On November 12, 2020, regulatory applications were submitted to the FDA and European Medicines Agency seeking approval of a subcutaneous form of daratumumab (Darzalex Faspro, daratumumab and hyaluronidase-fihj; Darzalex SC) in combination with pomalidomide and dexamethasone as treatment of patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.
FDA Approves Pembrolizumab Plus Chemotherapy for PD-L1+ Locally Recurrent Unresectable or Metastatic TNBC
The FDA granted approval to pembrolizumab (Keytruda) in combination with chemotherapy as treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 on November 13, 2020.
FDA Postpones Review of BLA for Liso-Cel in R/R Large B-Cell Lymphoma
The FDA did not complete its review of the Biologics License Application for lisocabtagene maraleucel (liso-cel) for the treatment of patients with relapsed/refractory large B-cell lymphoma after 2 prior lines of therapy by the Prescription Drug User Fee Act action date of November 16, 2020.
FDA Grants Fast Track Designation to Rilzabrutinib for Treatment of Immune Thrombocytopenia
The FDA granted a Fast Track designation on November 18, 2020, to rilzabrutinib, an oral investigational Bruton’s tyrosine kinase inhibitor, for the treatment of immune thrombocytopenia.
FDA Lifts Partial Clinical Hold from the MELANI-1 Study in Multiple Myeloma
On November 18, 2020, the FDA lifted a partial clinical hold placed on the phase 1 CAR T-cell clinical trial, MELANI-01.
FDA Approves Reduced Frequency Durvalumab Dosing Option in NSCLC
The FDA approved an additional dosing option for the approved indications of durvalumab (Imfinzi) at a 1500-mg fixed dose administered every 4 weeks on November 20, 2020.
FDA Grants Priority Review to Lonca in R/R Diffuse Large B-Cell Lymphoma
The FDA accepted a Biologic License Application on November 20, 2020, for loncastuximab tesirine (Lonca) as treatment of relapsed or refractory diffuse large B-cell lymphoma and granted it a Priority Review designation.
RV001 Granted FDA Fast Track Designation for Treatment of Prostate Cancer
On November 25, 2020, the FDA granted a Fast Track designation to RV001 for the potential treatment of patients with prostate cancer.
FDA Approves Naxitamab for Treatment of Relapsed/Refractory High-Risk Neuroblastoma
The FDA granted approval on November 25, 2020, to the naxitamab (Danyelza) as treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease on prior treatment.
Protocol Filed With FDA for Phase 2 Trial of Leronlimab to Treat Long-Hauler Symptoms of COVID-19
On November 27, 2020, a protocol was filed with the FDA for a phase 2 clinical trial aimed to evaluate leronlimab (PRO 140), which has been used to treat various solid tumors and hematologic malignancies, as treatment of patients with coronavirus disease 2019 (COVID-19) who are suffering from long-hauler symptoms.
FDA Grants Breakthrough Designation to Zanidatamab for HER2-Amplified Biliary Tract Cancer
The FDA granted a Breakthrough Therapy designation on November 30, 2020, to zanidatamab (formerly ZW25) as treatment of patients with previously treated HER2-amplified biliary tract cancer.
FDA Grants Fast Track Designation to Eprenetapopt for Treatment of TP53-Mutant AML
On November 30, 2020, the FDA granted a Fast Track designation to eprenetapopt (formerly APR-548) as treatment of patients with TP53-mutant acute myeloid leukemia.
FDA Grants Priority Review to Belumosudil for Chronic Graft-Versus-Host Disease
The FDA accepted the New Drug Application from belumosudil and granted it a Priority Review designation on November 30, 2020, for the treatment of patients with chronic graft-versus-host disease.