December 2025: Year-End FDA Oncology Actions at a Glance

December 2025 was a pivotal month in the oncology regulatory arena, defined by approvals actively reshaping the treatment landscape as well as designations spotlighting up-and-coming agents that are poised to make an impact across multiple cancer types. Approvals this month reflected both upfront traditional approvals and the conversion of several accelerated approvals to full approvals, solidifying earlier clinical advances into established standards of care.

Among key regulatory milestones this month were:

• The approval of the first chimeric antigen receptor (CAR) T-cell therapy for marginal zone lymphoma, lisocabtagene maraleucel.
• An inaugural FDA national priority voucher granted to the combination of teclistamab and daratumumab following compelling phase 3 data presented at the 67^th American Society of Hematology (ASH) Annual Meeting, bringing hope to patients with multiple myeloma.
• A series of fast track and breakthrough therapy designations accelerating the development and review of promising treatment candidates, such as fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for HER2-positive (HER2+) early breast cancer.

This comprehensive roundup captures the momentum sustained through the end of the year, encompassing FDA approvals, designations, and regulatory actions to cap off a fruitful year of oncology innovation and meaningful advances for patients.

Approvals

FDA Approves Novel Blood-Based Assay to Stratify Prostate Cancer Biopsy Risk

The FDA has granted premarket approval to the IsoPSA test, a novel, blood-based in vitro diagnostic kit designed to assist clinicians in deciding whether to proceed with prostate biopsy in men 50 years and older who present with elevated prostate-specific antigen levels.

FDA Approves Pegfilgrastim-unne for Nonmyeloid Cancers, Febrile Neutropenia

The FDA has approved pegfilgrastim-unne (Armlupeg) for the treatment of patients with nonmyeloid cancers who are undergoing treatment with myelosuppressive anticancer drugs linked to a significant risk of developing febrile neutropenia.

FDA Grants Traditional Approval to Pirtobrutinib in CLL/SLL

The FDA has granted traditional approval to pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor. This regulatory action converts the drug's previous accelerated approval to a full traditional approval.

FDA Approves Liso-Cel as First CAR T-Cell Therapy for Marginal Zone Lymphoma

The FDA has approved lisocabtagene maraleucel (liso-cel; Breyanzi), a CD19-directed CAR T-cell therapy, in marginal zone lymphoma.

FDA Approves Niraparib/Abiraterone Combo for BRCA2-Mutated mCSPC

The FDA has approved the fixed-dose combination of niraparib and abiraterone acetate (Akeega) plus prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

FDA Approves T-DXd Plus Pertuzumab for HER2-Positive Breast Cancer

The FDA has approved T-DXd plus pertuzumab (Perjeta) for the treatment of patients with HER2+ metastatic breast cancer.

FDA Grants Regular Approval to Rucaparib for BRCA-Mutated mCRPC

The FDA has granted regular approval to rucaparib (Rubraca) for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC). This regulatory decision converts the agency’s May 2020 accelerated approval to a full approval.

FDA Approves Subcutaneous Amivantamab for EGFR-Mutated NSCLC Indications

The FDA has approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for subcutaneous injection.¹ This new formulation is indicated for all adult patient populations previously approved for the intravenous formulation of amivantamab, primarily those with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR mutations.

FDA Approves Subcutaneous Mosunetuzumab in Follicular Lymphoma

The US FDA has approved mosunetuzumab-axgb (Lunsumio VELO) as a subcutaneous formulation for the treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma after 2 or more lines of systemic therapy.

Fast Track Designations

Novel T-Cell Engager CLN-049 Earns FDA Fast Track Status for R/R AML

CLN-049, a novel FLT3/CD3 bispecific T-cell engager, has received fast track designation (FTD) from the FDA for the treatment of R/R acute myeloid leukemia (AML).

FDA Fast-Tracks Zotiraciclib for Recurrent High-Grade mIDH Glioma

The FDA has granted FTD to zotiraciclib (TG02), an oral central nervous system-penetrant multikinase inhibitor, for treatment of patients with recurrent high-grade gliomas (rHGG) harboring IDH1/2 mutations (mIDH).

FDA Fast-Tracks Muzastotug Combo in MSS Metastatic Colorectal Cancer

The FDA has granted FTD to the combination of muzastotug (ADG126) plus pembrolizumab (Keytruda) in microsatellite-stable metastatic colorectal cancer (MSS mCRC).

BGB-B2033 Gains FDA Fast Track Status in Advanced HCC

The FDA has granted FTD to BGB-B2033, a novel GPC3x4-1BB bispecific antibody, for the treatment of advanced hepatocellular carcinoma (HCC).

CBI-1214 Receives IND and FTD for Colorectal Cancer

The US FDA has approved an investigational new drug (IND) application and granted FTD for CBI-1214, a T-cell engager being developed for the treatment of patients with colorectal cancer.

Breakthrough Therapy Designations

FDA Grants Breakthrough Therapy Designation to T-DXd in Early HER2+ BC

The FDA has granted breakthrough therapy designation (BTD) to T-DXd for the treatment of adult patients with HER2+ early breast cancer who have residual invasive disease following neoadjuvant systemic therapy and remain at high risk of recurrence.

FDA Grants Breakthrough Therapy Status to JSKN003 for Advanced Ovarian Cancer

The FDA has granted BTD to JSKN003, an investigational biparatopic HER2-targeting antibody-drug conjugate, for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers. The designation specifically applies to patients with HER2-expressing tumors (IHC 1+, 2+, or 3+) who have previously received bevacizumab (Avastin).

Orphan Drug Designations

Roxadustat Granted Orphan Drug Designation for Myelodysplastic Syndromes

The FDA has granted orphan drug designation to roxadustat (Evrenzo) for the treatment of patients with myelodysplastic syndromes.

NDA & BLA

FDA Grants Priority Review to Nivolumab-AVD in Classical Hodgkin Lymphoma

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with doxorubicin (Adriamycin), vinblastine, and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma (cHL). The FDA anticipates a final regulatory decision by the Prescription Drug User Fee Act target date of April 8, 2026.

Teclistamab/Daratumumab Earns FDA Priority Voucher for R/R Myeloma

The FDA has awarded a national priority voucher to the sBLA of teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro; Tec-Dara) for patients with R/R multiple myeloma.