| #
|
Approval date
|
Medication (Brand)
|
Company
|
Indication (short)
|
Regulatory type
|
Trial(s) cited on FDA approval page
|
FDA approval reference
|
| 1
|
2025-12-17
|
Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro)
|
Janssen Biotech, Inc.
|
Subcutaneous injection across approved amivantamab indications
|
Traditional approval
|
Trials
|
Reference
|
| 2
|
2025-12-17
|
Rucaparib (Rubraca)
|
pharmaand GmbH
|
BRCA-mutated mCRPC after androgen receptor–directed therapy
|
Traditional approval
|
Trials
|
Reference
|
| 3
|
2025-12-15
|
Fam-trastuzumab deruxtecan-nxki + pertuzumab (Enhertu + Perjeta)
|
Daiichi Sankyo, Inc.
|
1L unresectable/metastatic HER2+ breast cancer
|
Traditional approval
|
Trials
|
Reference
|
| 4
|
2025-12-12
|
Niraparib + abiraterone acetate + prednisone (Akeega)
|
Janssen Biotech, Inc.
|
BRCA2-mutated mCSPC
|
Traditional approval
|
Trials
|
Reference
|
| 5
|
2025-12-04
|
Lisocabtagene maraleucel (Breyanzi)
|
Juno Therapeutics, Inc. (BMS)
|
R/R marginal zone lymphoma after ≥2 prior lines
|
Traditional approval
|
Trials
|
Reference
|
| 6
|
2025-12-03
|
Pirtobrutinib (Jaypirca)
|
Eli Lilly and Company
|
R/R CLL/SLL after covalent BTKi
|
Traditional approval
|
Trials
|
Reference
|
| 7
|
2025-11-25
|
Durvalumab (Imfinzi) + FLOT → durvalumab
|
AstraZeneca
|
Resectable gastric/GEJ adenocarcinoma
|
Traditional approval
|
Trials
|
Reference
|
| 8
|
2025-11-21
|
Pembrolizumab (Keytruda/Keytruda Qlex) + enfortumab vedotin (Padcev)
|
Merck; Astellas Pharma
|
Neoadjuvant + adjuvant for MIBC (cisplatin-ineligible)
|
Traditional approval
|
Trials
|
Reference
|
| 9
|
2025-11-19
|
Tarlatamab-dlle (Imdelltra)
|
Amgen Inc.
|
ES-SCLC after platinum chemotherapy
|
Traditional approval
|
Trials
|
Reference
|
| 10
|
2025-11-19
|
Sevabertinib (Hyrnuo)
|
Bayer HealthCare Pharmaceuticals Inc.
|
HER2 (ERBB2) TKD–mutated non-squamous NSCLC after prior therapy
|
Accelerated approval
|
Trials
|
Reference
|
| 11
|
2025-11-19
|
Daratumumab + hyaluronidase-fihj (Darzalex Faspro) + VCd
|
Janssen Biotech Inc.
|
Newly diagnosed AL amyloidosis
|
Traditional approval
|
Trials
|
Reference
|
| 12
|
2025-11-19
|
Selumetinib (KOSELUGO)
|
AstraZeneca Pharmaceuticals LP
|
Adults with NF1 + symptomatic inoperable PN
|
Traditional approval
|
Trials
|
Reference
|
| 13
|
2025-11-18
|
Epcoritamab-bysp (Epkinly)
|
Genmab US, Inc.
|
Follicular lymphoma indications (combo + mono)
|
Traditional approval
|
Trials
|
Reference
|
| 14
|
2025-11-13
|
Pertuzumab-dpzb (Poherdy) — interchangeable biosimilar to Perjeta
|
Shanghai Henlius Biologics Co. Ltd.
|
Interchangeable biosimilar to pertuzumab
|
Traditional approval
|
Trials
|
Reference
|
| 15
|
2025-11-13
|
Ziftomenib (Komzifti)
|
Kura Oncology, Inc.
|
R/R AML with susceptible NPM1 mutation (no satisfactory alternatives)
|
Traditional approval
|
Trials
|
Reference
|
| 16
|
2025-11-06
|
Daratumumab + hyaluronidase-fihj (Darzalex Faspro)
|
Janssen Biotech, Inc.
|
High-risk smoldering multiple myeloma
|
Traditional approval
|
Trials
|
Reference
|
| 17
|
2025-10-24
|
Revumenib (Revuforj)
|
Syndax Pharmaceuticals, Inc.
|
R/R AML with susceptible NPM1 mutation
|
Traditional approval
|
Trials
|
Reference
|
| 18
|
2025-10-23
|
Belantamab mafodotin-blmf (Blenrep) + bortezomib + dexamethasone
|
GlaxoSmithKline
|
R/R multiple myeloma after ≥2 prior lines
|
Traditional approval
|
Trials
|
Reference
|
| 19
|
2025-10-08
|
Cemiplimab-rwlc (Libtayo)
|
Regeneron Pharmaceuticals Inc.
|
Adjuvant CSCC at high risk of recurrence after surgery + radiation
|
Traditional approval
|
Trials
|
Reference
|
| 20
|
2025-10-02
|
Lurbinectedin (Zepzelca) + atezolizumab (Tecentriq / Tecentriq Hybreza)
|
Jazz Pharmaceuticals, Inc.; Genentech Inc.
|
Maintenance for ES-SCLC after induction
|
Traditional approval
|
Trials
|
Reference
|
| 21
|
2025-09-25
|
Imlunestrant (Inluriyo)
|
Eli Lilly and Company
|
ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer after ≥1 endocrine line
|
Traditional approval
|
Trials
|
Reference
|
| 22
|
2025-09-19
|
Pembrolizumab + berahyaluronidase alfa-pmph (Keytruda Qlex)
|
Merck
|
Subcutaneous injection across approved pembrolizumab solid tumor indications
|
Traditional approval
|
Trials
|
Reference
|
| 23
|
2025-09-10
|
Selumetinib (KOSELUGO) granules/capsules
|
AstraZeneca Pharmaceuticals LP
|
Pediatric NF1 + symptomatic inoperable PN (≥1 year)
|
Traditional approval
|
Trials
|
Reference
|
| 24
|
2025-09-09
|
Gemcitabine intravesical system (Inlexzo)
|
Janssen Biotech, Inc.
|
BCG-unresponsive NMIBC with CIS ± papillary tumors
|
Traditional approval
|
Trials
|
Reference
|
| 25
|
2025-08-08
|
Zongertinib (Hernexeos)
|
Boehringer Ingelheim Pharmaceuticals, Inc.
|
HER2 TKD–mutated non-squamous NSCLC after prior therapy
|
Accelerated approval
|
Trials
|
Reference
|
| 26
|
2025-08-06
|
Dordaviprone (Modeyso)
|
Jazz Pharmaceuticals, Inc.
|
Diffuse midline glioma (H3 K27M) progressive after therapy
|
Accelerated approval
|
Trials
|
Reference
|
| 27
|
2025-07-02
|
Sunvozertinib (Zegfrovy)
|
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
|
EGFR exon 20 insertion NSCLC after platinum
|
Accelerated approval
|
Trials
|
Reference
|
| 28
|
2025-06-12
|
Mitomycin intravesical solution (Zusduri)
|
UroGen Pharma
|
Recurrent low-grade intermediate-risk NMIBC
|
Traditional approval
|
Trials
|
Reference
|
| 29
|
2025-06-11
|
Taletrectinib (Ibtrozi)
|
Nuvation Bio Inc.
|
ROS1+ locally advanced/metastatic NSCLC
|
Traditional approval
|
Trials
|
Reference
|
| 30
|
2025-06-03
|
Darolutamide (Nubeqa)
|
Bayer Healthcare Pharmaceuticals Inc.
|
Metastatic castration-sensitive prostate cancer
|
Traditional approval
|
Trials
|
Reference
|
| 31
|
2025-05-15
|
Retifanlimab-dlwr (Zynyz) + carbo/paclitaxel; also monotherapy
|
Incyte Corporation
|
Squamous cell carcinoma of the anal canal (SCAC)
|
Traditional approval
|
Trials
|
Reference
|
| 32
|
2025-05-14
|
Telisotuzumab vedotin-tllv (Emrelis)
|
AbbVie Inc.
|
c-Met high overexpression non-squamous NSCLC after prior therapy
|
Accelerated approval
|
Trials
|
Reference
|
| 33
|
2025-05-14
|
Belzutifan (Welireg)
|
Merck & Co., Inc.
|
Locally advanced/unresectable or metastatic PPGL (≥12 years)
|
Traditional approval
|
Trials
|
Reference
|
| 34
|
2025-05-08
|
Avutometinib + defactinib (Avmapki Fakzynja co-pack)
|
Verastem, Inc.
|
KRAS-mutated recurrent LGSOC after prior therapy
|
Accelerated approval
|
Trials
|
Reference
|
| 35
|
2025-04-23
|
Penpulimab-kcqx
|
Akeso Biopharma Co., Ltd.
|
1L recurrent/metastatic non-keratinizing NPC (with chemo)
|
Traditional approval
|
Trials
|
Reference
|
| 36
|
2025-04-11
|
Nivolumab (Opdivo) + ipilimumab (Yervoy)
|
Bristol Myers Squibb Company
|
1L unresectable/metastatic HCC
|
Traditional approval
|
Trials
|
Reference
|
| 37
|
2025-04-08
|
Nivolumab (Opdivo) + ipilimumab (Yervoy)
|
Bristol Myers Squibb Company
|
Unresectable/metastatic MSI-H/dMMR CRC (≥12 years)
|
Traditional approval
|
Trials
|
Reference
|
| 38
|
2025-03-28
|
Durvalumab (Imfinzi) + gem/cis → durvalumab
|
AstraZeneca
|
Muscle invasive bladder cancer (perioperative)
|
Traditional approval
|
Trials
|
Reference
|
| 39
|
2025-03-28
|
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) — indication expansion
|
Novartis Pharmaceuticals Corporation
|
PSMA+ mCRPC (earlier-line)
|
Traditional approval
|
Trials
|
Reference
|
| 40
|
2025-03-19
|
Mosunetuzumab-axgb (Lunsumio)
|
Genentech, Inc.
|
FL after ≥2 prior systemic therapies (peds/adults)
|
Traditional approval
|
Trials
|
Reference
|
| 41
|
2025-03-14
|
Tislelizumab-jsgr (Tevimbra)
|
BeiGene, Ltd.
|
Unresectable/metastatic ESCC (with platinum/fluoropyrimidine)
|
Traditional approval
|
Trials
|
Reference
|
| 42
|
2025-03-11
|
Nivolumab (Opdivo) + chemo
|
Bristol Myers Squibb Company
|
1L unresectable/advanced or metastatic gastric/GEJ adenocarcinoma
|
Traditional approval
|
Trials
|
Reference
|
| 43
|
2025-03-11
|
Pembrolizumab (Keytruda) + lenvatinib (Lenvima)
|
Merck; Eisai Inc.
|
Primary advanced/recurrent endometrial carcinoma
|
Traditional approval
|
Trials
|
Reference
|
| 44
|
2025-03-11
|
Pembrolizumab (Keytruda) + trastuzumab + chemo
|
Merck; Genentech, Inc.
|
1L HER2+ unresectable/advanced or metastatic gastric/GEJ adenocarcinoma
|
Traditional approval
|
Trials
|
Reference
|
| 45
|
2025-03-07
|
Durvalumab (Imfinzi) + chemo
|
AstraZeneca
|
1L ES-SCLC
|
Traditional approval
|
Trials
|
Reference
|
| 46
|
2025-02-14
|
Talquetamab-tgvs (Talvey)
|
Janssen Biotech, Inc.
|
R/R multiple myeloma (new dosing schedule)
|
Traditional approval
|
Trials
|
Reference
|
| 47
|
2025-02-13
|
Tislelizumab-jsgr (Tevimbra)
|
BeiGene, Ltd.
|
1L metastatic NSCLC (with pemetrexed/platinum)
|
Traditional approval
|
Trials
|
Reference
|
| 48
|
2025-02-12
|
Brentuximab vedotin (Adcetris) + lenalidomide + rituximab
|
Seagen Inc. (Pfizer)
|
R/R LBCL after ≥2 lines (HSCT/CAR-T ineligible)
|
Traditional approval
|
Trials
|
Reference
|
| 49
|
2025-02-11
|
Mirdametinib (Gomekli)
|
SpringWorks Therapeutics, Inc.
|
NF1 with symptomatic PN not amenable to resection (≥2 years)
|
Traditional approval
|
Trials
|
Reference
|
| 50
|
2025-02-06
|
Treosulfan (Grafapex) + fludarabine
|
medac GmbH
|
Preparative regimen for alloHSCT in AML/MDS
|
Traditional approval
|
Trials
|
Reference
|
| 51
|
2025-01-27
|
Fam-trastuzumab deruxtecan-nxki (Enhertu)
|
Daiichi Sankyo, Inc.
|
HR+ HER2-low/ultralow metastatic breast cancer after endocrine therapy
|
Traditional approval
|
Trials
|
Reference
|
| 52
|
2025-01-17
|
Datopotamab deruxtecan-dlnk (Datroway)
|
Daiichi Sankyo, Inc.
|
HR+, HER2– metastatic breast cancer after endocrine + chemo
|
Traditional approval
|
Trials
|
Reference
|
| 53
|
2025-01-16
|
Sotorasib + panitumumab (Lumakras + Vectibix)
|
Amgen Inc.
|
KRAS G12C-mutated mCRC after fluoropyrimidine/oxaliplatin/irinotecan
|
Traditional approval
|
Trials
|
Reference
|
| 54
|
2025-01-16
|
Acalabrutinib + bendamustine + rituximab (Calquence-based regimen)
|
AstraZeneca
|
Previously untreated mantle cell lymphoma (HSCT-ineligible)
|
Traditional approval
|
Trials
|
Reference
|
