Over the past year (December 2024–November 19, 2025), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers. The new approvals and accelerated approvals are listed below according to the most recent new drug approval date in 2025.
SELUMETINIB (KOSELUGO), a MEK1 and MEK2 inhibitor, was approved for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. The FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. November 19, 2025.
DARATUMUMAB AND HYALURONIDASE-FIHJ (DARZALEX FASPRO) was granted traditional approval with bortezomib/cyclophosphamide/dexamethasone for newly diagnosed light chain amyloidosis. The agent is a combination of the CD38 monoclonal antibody daratumumab and hyaluronidase, an enzyme that helps the drug spread through the body. The FDA granted accelerated approval to the regimen for this indication in 2021. November 19, 2025.
TARLATAMAB-DLLE (IMDELLTRA), a bispecific T-cell engager, which works by binding to the CD3 protein on T cells and the DLL3 protein on small cell lung cancer (SCLC) cells, was granted traditional approval for adults with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy. Tarlatamab received accelerated approval for this indication in 2024. November 19, 2025.
SEVABERTINIB (HYRNUO), a kinase inhibitor that targets HER2 and EGFR, received accelerated approval for adults with locally advanced or metastatic, nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. FDA also approved the Oncomine Dx Target Test as a companion diagnostic to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with nonsquamous NSCLC who may be eligible for treatment with sevabertinib. November 19, 2025.
EPCORITAMAB-BYSP (EPKINLY), a CD3xCD20 bispecific antibody, was approved in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab as monotherapy for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (accelerated approval was granted for this indication in 2024). November 18, 2025.
PERTUZUMAB-DPZB (POHERDY) was approved as an interchangeable biosimilar to pertuzumab (Perjeta), a monoclonal antibody targeting HER2. This is the first approval of a biosimilar for pertuzumab. November 13, 2025.
ZIFTOMENIB (KOMZIFTI), a menin inhibitor, was approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. November 13, 2025.
DARATUMUMAB AND HYALURONIDASE-FIHJ (DARZALEX FASPRO) injection was approved for adults with high-risk smoldering multiple myeloma. The agent is a combination of the CD38 monoclonal antibody daratumumab and hyaluronidase, an enzyme that helps the drug spread through the body. November 6, 2025.
REVUMENIB (REVUFORJ), a menin inhibitor, was approved for relapsed or refractory AML with a susceptible NPM1 mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. October 24, 2025.
BELANTAMAB MAFODOTIN-BLMF (BLENREP), a BCMA-directed antibody and microtubule inhibitor conjugate, was approved in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. October 23, 2025.
CEMIPLIMAB-RWLC (LIBTAYO), a human IgG4 anti–PD-1 monoclonal antibody, was approved for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. October 8, 2025.
LURBINECTEDIN (ZEPZELCA), a DNA alkylating agent, was approved in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide. October 2, 2025.
IMLUNESTRANT (INLURIYO), a selective estrogen receptor degrader, was approved for adults with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. September 25, 2025.
PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH (KEYTRUDA QLEX), a combination of the PD-1–blocking antibody and an enzyme that enables subcutaneous administration of pembrolizumab, was approved for subcutaneous injection for adult and pediatric patients 12 years and older with solid tumor indications already approved for intravenous pembrolizumab. September 19, 2025.
SELUMETINIB (KOSELUGO), a MEK1 and MEK2 inhibitor, was approved as granules and capsules for pediatric patients 1 year and older with NF1 who have symptomatic, inoperable plexiform neurofibromas. The FDA previously approved selumetinib capsules for pediatric patients 2 years and older. September 10, 2025.
GEMCITABINE INTRAVESICAL SYSTEM (INLEXZO) was approved for adults with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder. September 9, 2025.
ZONGERTINIB (HERNEXEOS), a HER2-selective tyrosine kinase inhibitor, was granted accelerated approval for adults with unresectable or metastatic nonsquamous NSCLC harboring mutations in the tyrosine kinase domain of the HER2 gene (HER2 TKD) who received prior systemic therapy. August 8, 2025.
DORDAVIPRONE (MODEYSO), a mitochondrial protease activator and a dopamine D2 receptor antagonist, was granted accelerated approval for adult and pediatric patients 1 year and older with diffuse midline glioma harboring a H3 K27M mutation with progressive disease following prior therapy. August 6, 2025.
SUNVOZERTINIB (ZEGFROVY), a tyrosine kinase inhibitor of EGFR, was granted accelerated approval for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy. July 2, 2025.
LINVOSELTAMAB-GCPT (LYNOZYFIC), a bispecific T-cell engager antibody, which works by binding to both the B-cell maturation antigen (BCMA) on cancer cells and the CD3 receptor on T cells, was granted accelerated approval for adults with relapsed/refractory multiple myeloma with four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. July 2, 2025.
DATOPOTAMAB DERUXTECAN-DLNK (DATROWAY), an antibody-drug conjugate that targets TROP2 was granted accelerated approval for adults with EGFR-mutated locally advanced/metastatic NSCLC who received prior EGFR-directed therapy and platinum chemotherapy. June 23, 2025.
TAFASITAMAB-CXIX (MONJUVI), a monoclonal antibody that targets the CD19 protein on the surface of B cells, was approved with lenalidomide and rituximab for adults with relapsed/refractory follicular lymphoma. June 18, 2025.
PEMBROLIZUMAB (KEYTRUDA), a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, was approved for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥ 1), as neoadjuvant therapy and continued adjuvantly. June 12, 2025.
MITOMYCIN INTRAVESICAL SOLUTION (ZUSDURI) was approved for adults with recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer. June 12, 2025.
TALETRECTINIB (IBTROZI), a tyrosine kinase inhibitor that works by binding to and blocking the activity of ROS1 and neurotrophic tyrosine receptor kinase (NTRK) proteins, was approved for adults with ROS1-positive locally advanced/metastatic NSCLC. June 11, 2025.
DAROLUTAMIDE (NUBEQA), an androgen receptor inhibitor, was approved for metastatic hormone-sensitive prostate cancer. June 3, 2025.
RETIFANLIMAB-DLWR (ZYNYZ), a PD-1 blocking antibody, was approved in combination with carboplatin and paclitaxel for first-line treatment of inoperable locally recurrent/metastatic squamous cell carcinoma of the anal canal. It was also approved as monotherapy for patients with anal squamous cell carcinoma with disease progression on or intolerance to platinum chemotherapy. May 15, 2025.
TELISOTUZUMAB VEDOTIN-TLLV (EMRELIS), an antibody-drug conjugate that targets cells overexpressing the c-Met protein, was granted accelerated approval for adults with metastatic nonsquamous NSCLC with high c-Met overexpression. May 14, 2025.
BELZUTIFAN (WELIREG), an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α), was approved for adults and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma. May 14, 2025.
AVUTOMETINIB AND DEFACTINIB (AVMAPKI FAKZYNJA CO-PACK), which target the RAS/RAF/MEK/ERK pathway (MAPK pathway) and the focal adhesion kinase (FAK) pathway, received accelerated approval for adults with KRAS-mutated previously treated low-grade serous ovarian cancer. May 8, 2025.
PENPULIMAB-KCQX (ANIKE), a PD-1–blocking antibody, was approved with a platinum agent plus gemcitabine for first-line treatment of recurrent/metastatic nonkeratinizing nasopharyngeal carcinoma. April 23, 2025.
NIVOLUMAB (OPDIVO) AND IPILIMUMAB (YERVOY) in combination was approved for first-line treatment of unresectable/metastatic hepatocellular carcinoma. Both agents are immunotherapy drugs. Nivolumab blocks PD-1; ipilimumab blocks the immune checkpoint CTLA-4. April 11, 2025.
NIVOLUMAB (OPDIVO) AND IPILIMUMAB (YERVOY) in combination was approved for microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer in patients 12 years and older; the FDA also converted nivolumab from accelerated to full approval. April 8, 2025.
DURVALUMAB (IMFINZI), a checkpoint inhibitor that targets PD-L1, was approved with gemcitabine/cisplatin as neoadjuvant treatment followed by adjuvant durvalumab after cystectomy for muscle-invasive bladder cancer. March 28, 2025.
LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (PLUVICTO), a targeted radiation therapy that works by binding to prostate-specific membrane antigen (PSMA) on prostate cancer cells, received expanded indication for patients with PSMA-positive metastatic hormone-resistant prostate cancer post–androgen receptor pathway inhibitor therapy who may delay taxane-based therapies. March 28, 2025.
CABOZANTINIB (CABOMETYX), a multi-tyrosine kinase inhibitor, primarily targeting receptor tyrosine kinases MET, AXL, and VEGFR, was approved for adults and pediatric patients 12 years and older with previously treated well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors. March 26, 2025.
PEMBROLIZUMAB (KEYTRUDA), an immunotherapy agent that binds to the PD-1 receptor, was approved with trastuzumab and chemotherapy for first-line treatment of locally advanced or metastatic HER2-positive gastric/gastroesophageal junction cancer with PD-L1 CPS ≥ 1. March 19, 2025.
VIMSELTINIB (ROMVIMZA), a selective inhibitor of the colony-stimulating factor 1 receptor, was approved for adults with symptomatic tenosynovial giant cell tumor where surgery may worsen functional status or cause severe morbidity. February 14, 2025.
BRENTUXIMAB VEDOTIN (ADCETRIS), a CD30 antibody-drug conjugate, was approved in combination with lenalidomide and rituximab in relapsed/refractory large B-cell lymphoma ineligible for transplant or CAR T-cell therapy. February 12, 2025.
MIRDAMETINIB (GOMEKLI), a highly selective, oral, non–ATP-competitive small molecule inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2), was approved for adult and pediatric patients 2 years of age and older with NF1 who have symptomatic plexiform neurofibromas not amenable to complete resection. February 11, 2025.
TREOSULFAN (GRAFAPEX), an alkylating agent, was approved with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplant in adults and children 1 year and older with AML or myelodysplastic syndromes. February 6, 2025.
FAM-TRASTUZUMAB DERUXTECAN-NXKI (ENHERTU), a HER2-directed monoclonal antibody, was approved for unresectable/metastatic hormone receptor–positive, HER2-low/ultralow breast cancer. January 27, 2025.
CAPECITABINE AND FLUOROURACIL, FDA updated product labeling regarding dihydropyrimidine dehydrogenase (DPD) deficiency–related toxicity risks. January 24, 2025.
DATOPOTAMAB DERUXTECAN-DLNK (DATROWAY), an antibody-drug conjugate that works by targeting TROP2-positive cancer cells with a monoclonal antibody, which then releases deruxtecan to damage DNA and kill the cancer cell, was approved for metastatic hormone receptor–positive, HER2-negative breast cancer after prior endocrine therapy and chemotherapy. January 17, 2025.
SOTORASIB (LUMAKRAS), a KRAS inhibitor, was approved with panitumumab for KRAS G12C–mutated metastatic colorectal cancer as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. January 16, 2025.
ACALABRUTINIB (CALQUENCE), a Bruton’s tyrosine kinase inhibitor, received approval with a bendamustine/rituximab regimen for untreated mantle cell lymphoma in transplant-ineligible adults. January 16, 2025.
NIVOLUMAB AND HYALURONIDASE-NVHY (OPDIVO QVANTIG) was approved for subcutaneous use across approved nivolumab, an anti-PD-1 antibody, indications. December 27, 2024.
ENCORAFENIB (BRAFTOVI), a BRAF inhibitor, received accelerated approval with cetuximab plus mFOLFOX6 for BRAF V600E–mutated metastatic colorectal cancer. December 20, 2024.
REMESTEMCEL-L-RKND (RYONCIL), an allogeneic bone marrow–derived mesenchymal stromal cell (MSC) therapy, was approved for steroid-refractory acute GVHD in pediatric patients 2 months and older. December 18, 2024.
ENSARTINIB (ENSACOVE), a tyrosine kinase inhibitor of ALK, was approved for untreated ALK-positive locally advanced/metastatic NSCLC. December 18, 2024.
COSIBELIMAB-IPDL (UNLOXCYT), a PD-L1 blocking antibody, was approved for metastatic or locally advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery/radiation. December 13, 2024.
DURVALUMAB (IMFINZI), a PD-L1 checkpoint inhibitor was approved for adults with limited-stage SCLC without disease progression after concurrent platinum-based chemotherapy and radiation therapy. December 4, 2024.
ZENOCUTUZUMAB-ZBCO (BIZENGRI), a bispecific antibody that targets both the HER2 and HER3 receptors, received accelerated approval for neuregulin 1 (NRG1) gene fusion–positive NSCLC or pancreatic cancer with progression after prior therapy. December 4, 2024.
