December 2024 Brief

R289, a dual IRAK1/4 inhibitor, has received fast track status from the FDA for treating transfusion-dependent lower-risk MDS in patients with inadequate responses to prior therapies.

The FDA granted breakthrough therapy status to sacituzumab tirumotecan in EGFR-mutated advanced non–small cell lung cancer.

With this approval, zenocutuzumab is the first FDA-approved therapy for patients with NRG1 fusion tumors.

CRB-701 has gained FDA fast track status for the treatment of adult patients with relapsed/refractory metastatic cervical cancer.

The FDA has accepted an sBLA for glofitamab plus gemcitabine and oxaliplatin in relapsed/refractory diffuse large B-cell lymphoma.

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

Cosibelimab is now FDA approved for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma that is not eligible for curative surgery or radiation.

The FDA granted breakthrough therapy designation to dostarlimab for locally advanced dMMR/MSI-H rectal cancer, highlighting its 100% clinical complete response rate in a phase 2 study.

The FDA granted breakthrough therapy designation to sacituzumab govitecan for patients with ES-SCLC progressing on platinum chemotherapy, supported by promising antitumor activity in the phase 2 TROPiCS-03 study.

The FDA issued a complete response letter for the BLA submission of subcutaneous amivantamab for EGFR-mutated NSCLC, citing manufacturing inspection issues, but confirming no need for additional clinical trials.

The FDA has granted ensartinib approval for adult patients with ALK-positive non–small cell lung cancer.

Following a complete response letter and biologics license application resubmission, the FDA has approved remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.

The FDA granted fast track designation to NX-5948 for treating relapsed/refractory Waldenström macroglobulinemia after 2 or more lines of therapy, including a BTK inhibitor.

The combination of encorafenib, cetuximab, and mFOLFOX6 has gained accelerated approval from the FDA for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation.

The FDA granted priority review to taletrectinib in ROS1-positive advanced NSCLC, with a target decision date of June 2025.

This approval marks the first and only approved subcutaneously administered PD-1 inhibitor.

The FDA has approved tislelizumab plus chemotherapy for the treatment of patients with newly diagnosed, locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.

A biologics license application for TLX250-CDx has been submitted to the FDA, as supported by the phase 3 ZIRCON trial showing high accuracy for ccRCC detection.

The FDA indicated paxalisib's overall survival data could support standard approval in glioblastoma, as supported by GBM-AGILE study findings.

Here is a look back on all the FDA happenings from the month of December 2024.