Nuclide regulatory events

Approval: Lutetium-177 dotatate (radioligand equivalent) (US, 2026-09-14)

2026-09-14T00:00:00Z

Bexlutry, NDA 218525 (Curium), original approval; FDA classification Type 5 new formulation or new manufacturer, standard review

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218525

Approval: Floretyrosine F-18 (FET) (US, 2026-09-11)

2026-09-11T00:00:00Z

Pixclara, NDA 218592 (Telix Pharmaceuticals US), original approval; FDA classification Type 1 new molecular entity

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218592

PDUFA date: 177Lu-edotreotide (US, 2026-08-28)

2026-08-28T00:00:00Z

PDUFA goal date for GEP-NET indication

Source: https://www.cancernetwork.com/view/fda-accepts-new-drug-application-for-177lu-edotreotide-in-gep-nets

Approval: Florquinitau F-18 (US, 2026-08-13)

2026-08-13T00:00:00Z

Tauklarify, NDA 220496 (Cerveau/Lantheus), original approval; FDA classification Type 1 new molecular entity, standard review

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220496

Approval: Lutetium-177 vipivotide tetraxetan (US, 2026-07-31)

2026-07-31T00:00:00Z

PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Label change: Enzalutamide (US, 2026-07-24)

2026-07-24T00:00:00Z

US Prescribing Information updated with overall survival data from EMBARK (NDA 203415/S-026, NDA 213674/S-016; efficacy labelling change with clinical data)

Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203415Orig1s026;213674Orig1s016ltr.pdf

Approval: Pembrolizumab (US, 2026-07-10)

2026-07-10T00:00:00Z

Muscle-invasive bladder cancer with enfortumab vedotin, as pembrolizumab or pembrolizumab with berahyaluronidase alfa

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin

Approval: Pembrolizumab (US, 2026-06-24)

2026-06-24T00:00:00Z

First-line PD-L1+ TNBC with sacituzumab govitecan (ASCENT-04)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line

Approval: Pembrolizumab (US, 2026-06-12)

2026-06-12T00:00:00Z

Adjuvant RCC with belzutifan (LITESPARK-022)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma

Approval: Gallium-68 gozetotide (PSMA-11) (US, 2026-06-08)

2026-06-08T00:00:00Z

Gallium Ga 68 gozetotide from RadioMedix approved under an abbreviated new drug application, ANDA 216410 (original approval)

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216410

Approval: Durvalumab (US, 2026-05-28)

2026-05-28T00:00:00Z

High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder

Approval: Florastamin F-18 (South Korea, 2026-04-30)

2026-04-30T00:00:00Z

MFDS marketing approval as Korea's 43rd domestically developed new drug

Source: https://en.sedaily.com/finance/2026/05/04/futurechem-wins-approval-for-koreas-first-prostate-cancer

Approval: Technetium (99mTc) pexiretide (China, 2026-04-02)

2026-04-02T00:00:00Z

NMPA marketing approval (priority review), trade name Jilunte

Source: https://www.nsfc.gov.cn/p1/3381/2825/121910.html

Approval: Piflufolastat F-18 / Pylarify TruVu (US, 2026-03-09)

2026-03-09T00:00:00Z

Pylarify TruVu formulation

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2026-Q1)

2026-02-15T00:00:00Z

Platinum-resistant PD-L1+ ovarian cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2025-11)

2025-11-15T00:00:00Z

Perioperative gastric/GEJ cancer with FLOT (MATTERHORN)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2025-09)

2025-09-15T00:00:00Z

Subcutaneous pembrolizumab (Keytruda Qlex)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2025-03-28)

2025-03-28T00:00:00Z

Perioperative muscle-invasive bladder cancer (NIAGARA)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 vipivotide tetraxetan (US, 2025-03-28)

2025-03-28T00:00:00Z

PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Cabozantinib (US, 2025-03-26)

2025-03-26T00:00:00Z

NET indication on CABINET

Source: https://www.ncf.net/post/2025-highlights-in-neuroendocrine-cancer

Designation: 177Lu-edotreotide (US, 2025-03)

2025-03-15T00:00:00Z

COMPETE topline at ENETS 2025

Source: https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-presents-positive-topline-phase-3-compete-trial-data-with-nca-177lu-edotreotide-itm-11-a-targeted-radiopharmaceutical-therapy-in-patients-with-grade-1-or-2-gastroenteropancreatic-neuroendocrine-tumors-at-the-enets-2025-conference-688/

Withdrawal: Technetium (99mTc) pexiretide (China, 2025-02)

2025-02-15T00:00:00Z

An earlier new drug application for the same product was withdrawn before being resubmitted; reported by Chinese trade press, not by the regulator

Source: https://www.163.com/dy/article/K0V13Q6H05118K9D.html

Approval: Durvalumab (US, 2024-12-04)

2024-12-04T00:00:00Z

Limited-stage SCLC after chemoradiation (ADRIATIC)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Flurpiridaz F-18 (US, 2024-09-27)

2024-09-27T00:00:00Z

FDA approved Flyrcado (flurpiridaz F 18) injection, NDA 215168, for PET myocardial perfusion imaging under rest or stress (pharmacologic or exercise) in adults with known or suspected CAD.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215168Orig1s000Approv.pdf

Filing: Actinium-225 PSMA agents (US, 2024-06)

2024-06-15T00:00:00Z

AstraZeneca completes Fusion Pharmaceuticals acquisition; FPI-2265 phase 3 planned

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Label change: Lutetium-177 dotatate (US, 2024-06)

2024-06-15T00:00:00Z

First-line label based on NETTER-2

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 dotatate (US, 2024-04-23)

2024-04-23T00:00:00Z

Paediatric patients ≥12 years

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: Actinium-225 DOTATATE (US, 2024-02-26)

2024-02-26T00:00:00Z

BMS completes RayzeBio acquisition ($4.1B)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2023-10-16)

2023-10-16T00:00:00Z

Perioperative NSCLC (KEYNOTE-671)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Technegas (technetium Tc-99m labelled carbon inhalation aerosol) (US, 2023-09-29)

2023-09-29T00:00:00Z

FDA approval of NDA 022335 (Cyclomedica Australia), Type 3 new dosage form

Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022335Orig1s000Approv.pdf

Approval: Olaparib (US, 2023-05-31)

2023-05-31T00:00:00Z

With abiraterone in BRCA-mutated mCRPC (PROpel)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: FAP-2286 (177Lu / 68Ga) (US, 2023-01)

2023-01-15T00:00:00Z

Novartis acquires rights after Clovis bankruptcy

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 vipivotide tetraxetan (EU, 2022-12)

2022-12-15T00:00:00Z

EMA approval

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2022-10-21)

2022-10-21T00:00:00Z

HCC with tremelimumab (HIMALAYA)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2022-09-02)

2022-09-02T00:00:00Z

Biliary tract cancer with chemotherapy (TOPAZ-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 vipivotide tetraxetan (US, 2022-03-23)

2022-03-23T00:00:00Z

PSMA+ mCRPC after ARPI and taxane (VISION)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2022-03-11)

2022-03-11T00:00:00Z

Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2021-07-26)

2021-07-26T00:00:00Z

High-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Designation: Lutetium-177 vipivotide tetraxetan (US, 2021-06)

2021-06-15T00:00:00Z

Breakthrough Therapy designation

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Piflufolastat F-18 / Pylarify TruVu (US, 2021-05-26)

2021-05-26T00:00:00Z

PSMA PET imaging in prostate cancer: first 18F PSMA agent

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2020-11-13)

2020-11-13T00:00:00Z

Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2020-06-16)

2020-06-16T00:00:00Z

TMB-high solid tumours (tumour-agnostic)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2020-05-19)

2020-05-19T00:00:00Z

HRR-mutant mCRPC (PROfound)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2020-03-27)

2020-03-27T00:00:00Z

Extensive-stage SCLC with chemotherapy (CASPIAN)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2019-12-27)

2019-12-27T00:00:00Z

gBRCA metastatic pancreatic cancer maintenance (POLO)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2018-12-19)

2018-12-19T00:00:00Z

First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2018-02-16)

2018-02-16T00:00:00Z

Unresectable stage III NSCLC after chemoradiation (PACIFIC)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 dotatate (US, 2018-01-26)

2018-01-26T00:00:00Z

SSTR+ gastroenteropancreatic NETs (NETTER-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2018-01-12)

2018-01-12T00:00:00Z

gBRCA HER2-negative metastatic breast cancer (OlympiAD)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 dotatate (EU, 2017-09-26)

2017-09-26T00:00:00Z

EMA approval: first modern PRRT

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2017-08-17)

2017-08-17T00:00:00Z

Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2017-05-23)

2017-05-23T00:00:00Z

MSI-H/dMMR solid tumours: first tumour-agnostic approval

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Durvalumab (US, 2017-05-01)

2017-05-01T00:00:00Z

Urothelial carcinoma (accelerated; later withdrawn 2021)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2015-10-02)

2015-10-02T00:00:00Z

PD-L1+ NSCLC after platinum

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Olaparib (US, 2014-12-19)

2014-12-19T00:00:00Z

gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2014-09-04)

2014-09-04T00:00:00Z

Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Withdrawal: Iodine-131 tositumomab (US/CA, 2014-02-20)

2014-02-20T00:00:00Z

Marketing of the Bexxar therapeutic regimen formally discontinued.

Source: https://openmedscience.com/the-rise-and-fall-of-iodine-131-tositumomab-bexxars-story/

Withdrawal: Iodine-131 tositumomab (US/CA, 2013-08-06)

2013-08-06T00:00:00Z

GlaxoSmithKline announced it would discontinue manufacture and sale of the Bexxar regimen, citing declining use (about 75 US patients in 2012) and available alternative therapies.

Source: https://pipelinereview.com/gsk-to-discontinue-manufacture-and-sale-of-the-bexxar-therapeutic-regimen-tositumomab-and-iodine-i-131-tositumomab/

Approval: Sorafenib (US, 2007-11-16)

2007-11-16T00:00:00Z

Unresectable HCC on SHARP

Approval: Radioactive iodine (I-131) (US, 1946)

1946-06-30T00:00:00Z

First therapeutic use in thyroid cancer (Seidlin); formal approval followed