EP. 1: FDA Grants Orphan Drug Designation to Azeliragon for Patients with GlioblastomaJanuary 10th 2023
Azeliragon has been granted an orphan drug designation by the FDA for patients with glioblastoma after previous trials demonstrated the agent to be well-tolerated in Alzheimer’s disease.
EP. 2: FDA to Review BLA for Perioperative Pembrolizumab/Chemotherapy for Stage II-IIIB NSCLCMarch 1st 2023
With statistically significant and clinically meaningful event-free survival improvement in patients with stage II-IIIB Non–small cell lung cancer, could perioperative pembrolizumab in combination with chemotherapy become a new treatment option?
EP. 3: FDA Receives NDA for Niraparib Plus Abiraterone and Prednisone for BRCA+ mCRPCMarch 1st 2023
Data from the second interim analysis of the phase 3 MAGNITUDE study showed that the addition of niraparib to abiraterone acetate and prednisone prolonged survival for patients with metastatic castration-resistant prostate cancer with BRCA mutations.
EP. 11: FDA’s ODAC Votes for Polatuzumab Plus R-CHP for Previously Untreated DLBCLMarch 9th 2023
In a vote of 11 to 2, the FDA's Oncologic Drugs Advisory Committee voted for the benefit/risk profile of polatuzumab vedotin in combination with R-CHP, based on findings from the confirmatory POLARIX trial.
EP. 13: FDA OKs Pegfilgrastim Biosimilar to Decrease Chemo-Associated Febrile NeutropeniaMarch 10th 2023
A comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study has led the FDA to approve the pegfilgrastim biosimilar pegfilgrastim-cbqv for patients with cancer.
EP. 17: FDA Approves Dabrafenib Plus Trametinib for Pediatric BRAF V600E-Mutant Low-Grade GliomaMarch 16th 2023
Findings from the phase 2 Study CDRB436G2201 trial have led the FDA to approve dabrafenib combined with trametinib for pediatric patients with BRAF V600E-mutated low-grade glioma who require systemic therapy.
EP. 18: FDA Grants FTD to PBP1510 for Unresectable/Metastatic Pancreatic AdenocarcinomaMarch 21st 2023
PBP1510 has received a fast track designation from the FDA for patients with unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least 1 prior line therapy.
EP. 19: ISB 1442 Lands FDA Orphan Drug Status for R/R Multiple MyelomaMarch 22nd 2023
ISB 1442, a 2+1 biparatopic bispecific antibody that has CD38 and CD47 targeting domains, has received an orphan drug designation from the FDA and is being assessed in a phase 1/2 clinical trial for patients with multiple myeloma.
EP. 21: FDA Grants FORE8394 Orphan Drug Designation for Primary Brain/CNS MalignanciesMarch 22nd 2023
The first orphan drug designation from the FDA has been received by FORE Biotherapeutics and for the FORE8394 program for patients with primary brain and central nervous system malignancies.
EP. 23: FDA Issues Complete Response Letter to Ruxolitinib XR Tablets for MPNsMarch 24th 2023
The FDA noted that additional requirements are needed prior to the approval of ruxolitinib extended-release for patients with myelofibrosis, polycythemia vera, and graft-versus-host disease, in a complete response letter.
EP. 24: FDA Draft Guidance Supports Randomized Trials for Accelerated ApprovalsMarch 28th 2023
The FDA released a draft guidance for drug sponsors of clinical trials in oncology, outlining its move toward requiring randomized controlled trials to grant accelerated approvals for most oncology therapeutics.
EP. 25: FDA Lifts Partial Hold on Phase 1/2 VELA Trial of BLU-222 for Solid TumorsMarch 29th 2023
As of March 28, 2023, the partial clinical hold on the phase 1/2 VELA trial, which is evaluating the selective CDK2 inhibitor BLU-222 for patients with solid tumors, has been lifted. Blueprint Medicines has resumed the re-initiation of patient enrollment.
EP. 26: FDA Grants Full Approval to Pembrolizumab for MSI-H and dMMR Solid TumorsMarch 29th 2023
A full approval has been granted to pembrolizumab by the FDA for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors.
EP. 27: FDA Green Lights FTD of RRx-001 to Mitigate Severe Oral Mucositis in Head and Neck CancersMarch 30th 2023
The FDA has granted a fast-track designation for RRx-001 and accepted the investigational new drug application for a phase 2b trial of severe oral mucositis in chemotherapy- and radiation-treated patients with head & neck cancer.
EP. 28: FDA Accepts IND for GRC 54276 in Advanced Solid Tumors and LymphomasMarch 31st 2023
A phase 1/2 trial investigating GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas will begin following the acceptance of an investigational new drug application for the agent.