FDA Grants Key Oncology Approvals and Designations in January 2025

In January 2025, the FDA granted several key approvals in oncology, including acalabrutinib (Calquence) with bendamustine and rituximab (Rituxan) for untreated patients with mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation, sotorasib (Lumakras) plus panitumumab (Vectibix) in KRAS G12C–mutant metastatic colorectal cancer, and datopotamab deruxtecan (Dato-DXd) in unresectable or metastatic hormone receptor–positive/HER2-negative breast cancer who have received prior systemic therapy.

The FDA also granted priority reviews for multiple therapies, including sunvozertinib (DZD9008), for patients with EGFR exon 20 insertion mutations in NSCLC, and belzutifan (Welireg) for advanced, unresectable pheochromocytoma and paraganglioma. Fast track designations were granted to several therapies, including emiltatug ledadotin (XMT-1660) for patients with advanced or metastatic HER2-low or HER2-negative breast cancer, as well as abenacianine (VGT-309) for use as an adjunct during lung cancer surgery.

Several investigational therapies also received supportive designations. The FDA granted orphan drug status to amezalpat (TPST-1120) for hepatocellular carcinoma, and MB-105 in relapsed/refractory CD5-positive T-cell lymphoma. Fast track designations were granted to invikafusp alfa (STAR0602) in advanced high tumor mutation burden colorectal cancer and LYT-200 in acute myeloid leukemia (AML).

Here is a look back on all the FDA happenings from the month of January 2025.

Amezalpat Gains FDA Orphan Drug Status in HCC

On January 6, 2025, the FDA granted amezalpat (TPST-1120) orphan drug designation for the treatment of patients with hepatocellular carcinoma.

FDA Releases Draft Guidance on Confirmatory Trials for Accelerated Approvals

Also on January 6, 2025, the FDA issued a draft guidance that describes the criteria for confirmatory trials in accelerated approvals.

FDA Grants Priority Review to Sunvozertinib in EGFR+ NSCLC

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR inhibitor, for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, identified using an FDA-approved test.

FDA Fast Tracks Abenacianine for Lung Cancer Surgery

Also on January 7, 2025, the FDA granted fast track designation to abenacianine for injection (VGT-309) for use as an adjunct during surgery.

FDA Grants B7-H3–Targeted ADC Breakthrough Status in Osteosarcoma

The FDA granted breakthrough therapy designation to GSK5764227 (GSK’227) for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed after at least 2 prior lines of therapy, also on January 7, 2025.

FDA Clears Investigational New Drug Application for REC-4539 in SCLC

The FDA cleared an investigational new drug application for a phase 1/2 clinical trial to investigate REC-4539 on January 7, 2025.

FDA Grants Fast Track Designation to Invikafusp Alfa in TMB-H Colorectal Cancer

On January 8, 2025, invikafusp alfa (STAR0602) received fast track designation for treating advanced high tumor mutation burden colorectal cancer.

FDA Grants R289 Orphan Drug Designation in MDS

The FDA granted R289 orphan drug designation for treating patients with myelodysplastic syndromes on January 9, 2025.

FDA Grants BBO-8520 Fast Track Status in KRAS G12C-Mutant NSCLC

On January 9, 2025, the FDA granted fast track designation to BBO-8520 in previously treated, KRAS G12C–mutated metastatic non–small cell lung cancer.

LYT-200 Gains FDA Fast Track Status in Acute Myeloid Leukemia

Also on January 9, 2025, the FDA granted fast track designation to LYT-200 for the treatment of acute myeloid leukemia.

FDA Clears NMIBC Agent TYRA-300 for Phase 2 Trial

On January 10, 2025, the FDA cleared the investigational new drug application for TYRA-300 in low-grade, intermediate-risk non–muscle-invasive bladder cancer.

FDA Grants Clearance for Phase 1b/2 Trial of SNB-101 in SCLC

The FDA granted clearance to the investigational new drug application of SNB-101 in small cell lung cancer treatment, also on January 10, 2025.

FDA Fast Tracks Emiltatug Ledadotin in Advanced/Metastatic Breast Cancer

Also on January 10, 2025, the FDA granted fast track designation to emiltatug ledadotin (Emi-Le; XMT-1660) for patients with advanced or metastatic breast cancer, specifically those with HER2-low or HER2-negative disease, including triple-negative breast cancer.

FDA Grants Fast Track Designation to LOAd703 in Pancreatic Cancer

On January 10, 2025, the FDA granted fast track designation to LOAd703 for treating patients with pancreatic cancer.

FDA Grants Lete-cel BTD in Myxoid/Round Cell Liposarcoma

The FDA granted a breakthrough therapy designation to letetresgene autoleucel (lete-cel) on January 13, 2025, for the treatment of patients with unresectable or metastatic myxoid/round cell liposarcoma.

FDA Clears Novel Cancer Immunotherapy R-5780 for Early-Stage Trial

Also on January 13, 2025, the FDA has accepted the investigational new drug application to proceed with a phase 1 clinical trial of R-5780 in patients with cancer.

FDA Grants Priority Review to Dato-DXd in Advanced EGFR-Mutated NSCLC

The FDA has accepted and granted priority review to the biologics license application for datopotamab deruxtecan (Dato-DXd) on January 14, 2025.

FDA to Review 3-Month Leuprolide Mesylate for Prostate Cancer Treatment

The FDA issued a Day-74 letter setting August 29, 2025, as the Prescription Drug User Fee Act date for the 3-month leuprolide mesylate (Camcevi) formulation for advanced prostate cancer, also on January 14, 2025.

FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC

On January 15, 2025, the FDA received a new drug application for TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non–muscle-invasive bladder cancer with carcinoma in situ.

FDA Clears 225Ac-SSO110 for Phase 1/2 SCLC and Merkel Cell Carcinoma Trial

On January 14, 2025, the FDA cleared its investigational new drug application, allowing for the start of a phase 1/2 trial of 225Ac-SSO110 (satoreotide) for the treatment of patients with small cell lung cancer or Merkel cell carcinoma.

FDA Approves Axatilimab for Chronic GVHD in New Vial Sizes

The FDA granted approval to axatilimab-csfr (Niktimvo) in 9 mg and 22 mg vial sizes on January 15, 2025.

FDA Issues Complete Response Letter for Tab-cel in EBV+ PTLD

A complete response letter was issued by the FDA in response to the biologics license application seeking the approval of tabelecleucel (tab-cel; Ebvallo) for the treatment of Epstein-Barr virus–positive post-transplant lymphoproliferative disease on January 16, 2025.

Acalabrutinib Plus Bendamustine and Rituximab Receives FDA Approval in MCL

The FDA approved acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan; BR) on January 16, 2025, for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.

FDA Oks Sotorasib/Panitumumab in KRAS G12C–Mutant Colorectal Cancer

The FDA also approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) on January 16, 2025, for the treatment of patients with previously treated KRAS G12C-mutated metastatic colorectal cancer.

FDA Grants Breakthrough Status to DCISionRT Test in DCIS

The FDA granted breakthrough therapy designation to the DCISionRT test for patients with ductal carcinoma in situ on January 16, 2025.

FDA Approves FoundationOne CDx as Companion Diagnostic for Tovorafenib in Pediatric Low-Grade Glioma

The FDA granted approval to FoundationOne CDx as the first companion diagnostic for tovorafenib (Ojemda) for patients with relapsed or refractory pediatric low-grade glioma (pLGG) with BRAF mutations or rearrangements on January 17, 2025.

FDA Approves Dato-DXd in HR+/HER2– Breast Cancer

The FDA approved datopotamab deruxtecan (Dato-DXd) for the treatment of patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have received prior systemic therapy, also on January 17, 2025.

FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma

The FDA accepted the biologics license application for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for the treatment of patients with advanced melanoma on January 21, 2025.

FDA Supports Registrational Strategy for ELI-002 in KRAS-Driven Cancers

On January 22, 2025, the FDA provided supportive feedback in an end of phase 1 type B meeting about the registrational strategy for ELI-002.

FDA Greenlights Treosulfan/Fludarabine Combo for AlloHSCT in AML and MDS

Also on January 22, 2025, the FDA has granted approval to the combination of treosulfan (Grafapex) and fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation.

FDA Grants FTD to 64Cu-SAR-bisPSMA for PET Imaging in Prostate Cancer

The FDA has granted fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging of prostate-specific membrane antigen positive prostate cancer lesions for the treatment of patients with biochemical recurrence of prostate cancer after definitive therapy on January 24, 2025.

FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma

The FDA granted priority review to a supplemental new drug application seeking the approval of belzutifan (Welireg) on January 27, 2025, for the treatment of patients aged 12 years and older with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

FDA Grants Orphan Drug Designation to MB-105 for R/R T-Cell Lymphoma

On January 28, 2025, the FDA granted MB-105 orphan drug designation for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.