EP. 4: FDA Receives BLA Resubmission of Remestemcel-L for Pediatric SR-aGVHDFebruary 2nd 2023
As requested by the FDA, a new biologics license application including updated scientific rationale has been submitted for remestemcel-L as treatment for patients with steroid-refractory acute graft-vs-host disease.
EP. 6: FDA Accepts Denosumab Biosimilar BLA for Treatment-Related Bone Loss in CancerFebruary 9th 2023
Based on findings from the ROSALIA study, the FDA has accepted for review a proposed denosumab biosimilar for patients with osteoporosis and treatment-related bone loss in patients with cancer.
EP. 8: FDA's ODAC Supports Proposed Trials for Dostarlimab in dMMR/MSI-H Locally-Advanced Rectal CancersFebruary 9th 2023
In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee supported the proposed clinical trial for dostarlimab as treatment of locally advanced, treatment-naïve mismatch-repair deficient or microsatellite-instability-high rectal cancer.
EP. 13: FDA Grants Priority Review to BLA of Elranatamab for R/R Multiple MyelomaFebruary 22nd 2023
Results from cohort A of the MagnetisMM–3 trial of erlanatamab for patients with relapsed/refractory multiple myeloma have led the FDA to grant priority review to a biologics license application for the agent in this patient population.
EP. 14: FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk MelanomaFebruary 23rd 2023
The FDA has granted a breakthrough therapy designation to mRNA-4157/V940 based on data from KEYNOTE-942 which showed that the addition of an mRNA vaccine to adjuvant pembrolizumab improved recurrence-free survival following resection of high-risk melanoma.
EP. 15: FDA Okays IND Application of BA3182 for Advanced AdenocarcinomaFebruary 24th 2023
A phase 1 dose-escalation and -expansion clinical trial will evaluate BA3182, a potential anticancer therapy, for patients with advanced adenocarcinoma based on the clearance of an investigational new drug application from the FDA.
EP. 16: FDA Grants Priority Review to NDA of Nirogacestat for Desmoid TumorsFebruary 27th 2023
Data from the phase 3 DeFi trial showed that nirogacestat led to a 71% reduction in the risk of disease progression compared with placebo for adult patients with desmoid tumors. Now, the FDA has granted a priority review to the new drug application for nirogacestat.
EP. 18: FDA Accepts sBLA of Nivolumab Monotherapy for Stage IIB/IIC MelanomaFebruary 28th 2023
Efficacy findings from CheckMate-76 have led the FDA to accept the supplemental biologics license application and the EMA to validate the type II variation marketing authorization application for nivolumab alone in stage IIB or IIC melanoma.