FDA’s December 2024 Oncology Approvals and Designations

December 2024 saw notable FDA approvals, including zenocutuzumab (formerly MCLA-128) for NRG1-positive non–small cell lung cancer (NSCLC) and pancreatic cancer, and cosibelimab (formerly CK-301) for metastatic or locally advanced cutaneous squamous cell carcinoma. The combination of encorafenib (Braftovi), cetuximab (Erbitux), and chemotherapy for BRAF V600E-positive metastatic colorectal cancer was also approved by the FDA, as well as subcutaneous nivolumab (Opdivo) across various solid tumors, and tislelizumab (Tevimbra) plus chemotherapy for the first-line treatment of gastric or gastroesophageal junction cancer.

The agency also granted fast track designations to R289 for lower-risk myelodysplastic syndrome and CRB-701 for relapsed/refractory metastatic cervical cancer, and breakthrough therapy designations to sacituzumab tirumotecan (SKB264/MK-2870) for advanced EGFR-mutated NSCLC and to sacituzumab govitecan-hziy (Trodelvy) for extensive-stage small cell lung cancer treatment.

In addition, the FDA issued key regulatory updates, including a priority review for taletrectinib in ROS1-positive advanced NSCLC and the approval of remestemcel-L (Ryoncil) for pediatric patients with acute graft-vs-host disease.

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

FDA Grants Fast Track Designation to R289 for LR-MDS Treatment

On December 2, 2024, the FDA granted fast track designation to R289 for use in patients with previously treated transfusion dependent lower-risk myelodysplastic syndrome.

FDA Grants Breakthrough Status to Sacituzumab Tirumotecan in EGFR+ NSCLC

The FDA granted sacituzumab tirumotecan (SKB264/MK-2870) breakthrough therapy designation in patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring EGFR mutations, whose disease progressed following a tyrosine kinase inhibitor and platinum-based chemotherapy on December 3, 2024.

FDA Grants CRB-701 Fast Track Status in R/R Cervical Cancer

On December 3, 2024, the FDA granted fast track designation to CRB-701 (SYS6002) in relapsed/refractory metastatic cervical cancer.

Zenocutuzumab Now FDA-Approved in NRG1+ NSCLC and Pancreatic Cancer

The FDA approved zenocutuzumab (formerly MCLA-128) on December 3, 2024, for the treatment of patients with NRG1-positive NSCLC and NRG1-positive pancreatic ductal adenocarcinoma.

FDA Accepts sBLA for Glofitamab Plus Chemo in DLBCL

The FDA accepted a supplemental biologics license application for glofitamab-gxbm (Columvi) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma on December 5, 2024.

FDA Grants Priority Review to Durvalumab in MIBC

On December 6, 2024, the supplemental biologics license application for durvalumab (Imfinzi) was accepted and granted priority review by the FDA for muscle-invasive bladder cancer.

FDA Greenlights Cosibelimab in Metastatic or Locally Advanced CSCC

On December 13, 2024, the FDA approved cosibelimab (formerly CK-301) for metastatic or locally advanced cutaneous squamous cell carcinoma.

FDA Grants Dostarlimab Breakthrough Therapy Designation in dMMR/MSI-H Rectal Cancer

Breakthrough therapy designation was granted to dostarlimab-gxly (Jemperli) from the FDA on December 16, 2024, for the treatment of patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.

FDA Issues CRL for SC Amivantamab BLA in EGFR+ NSCLC

Also on December 16, 2024, a complete response letter from the FDA was issued to the biologics license application submission for amivantamab-vmjw (Rybrevant) and recombinant human hyaluronidase for subcutaneous administration.

FDA Grants Breakthrough Status to Sacituzumab Govitecan in ES-SCLC

The FDA granted breakthrough therapy designation to sacituzumab govitecan (Trodelvy) for treating extensive-stage small cell lung cancer in adult patients whose disease has progressed on or following platinum-based chemotherapy on December 17, 2024.

FDA Approves Ensartinib in ALK-Positive NSCLC

On December 18, 2024, ensartinib received FDA approval for the first-line treatment of anaplastic lymphoma kinase-positive locally advanced or metastatic NSCLC.

FDA Approves Remestemcel-L in Pediatric Patients With Acute GVHD

The FDA also approved remestemcel-L (Ryoncil) for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease on December 18, 2024.

FDA Grants NX-5948 Fast Track Designation in R/R Waldenström Macroglobulinemia

The FDA granted fast track designation to NX-5948, a brain-penetrant, orally bioavailable BTK degrader, on December 19, 2024, for treating relapsed/refractory Waldenström macroglobulinemia after 2 or more lines of therapy.

FDA Grants Accelerated Approval to Encorafenib/Cetuximab/Chemo Combo in BRAF V600E+ mCRC

On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

FDA Grants Taletrectinib Priority Review in ROS1+ Advanced NSCLC

The FDA granted priority review to the new drug application) for taletrectinib, a treatment for patients with ROS1-positive advanced NSCLC, on December 23, 2024.

FDA Approves Subcutaneous Nivolumab Across Existing Solid Tumor Indications

On December 27, 2024, subcutaneous nivolumab (Opdivo Qvantig) was approved by the FDA in all previously approved adult solid tumor indications of the agent as monotherapy or monotherapy maintenance or in combination with chemotherapy or cabozantinib (Cabometyx).

Tislelizumab Scores FDA Approval in Advanced Gastric and GEJ Cancers

Tislelizumab (Tevimbra), an anti–PD-1 monoclonal antibody, plus chemotherapy received FDA approval on December 27, 2024, for the first-line treatment of gastric or gastroesophageal junction cancer.

FDA Considers Approval of TLX250-CDx in Kidney Cancer

The FDA received a submission of a biologics license application for TLX250-CDx (Zircaix, ⁸⁹Zr-DFO-girentuximab) kidney cancer imaging on December 30, 2024.

FDA Signals Potential for Standard Approval of Paxalisib in Glioblastoma

On December 31, 2024, the FDA stated overall survival data for paxalisib (formerly GDC-0084) in glioblastoma may support standard approval but not accelerated approval.