2025 in cancer

FDA · US: 164 records / 76 drugsHealth Canada · CA: 60 records / 34 drugsEMA · EU: 47 records / 22 drugs

• Nov 19, 2025Sevabertinib FDA · US original application accelerated approved Lung Non-Squamous Non-Small Cell CarcinomaHYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have…openfda
• Nov 13, 2025Ziftomenib FDA · US original application approved Acute Myeloid LeukemiaKOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 )…openfda
• Oct 29, 2025Denosumab FDA · US original application approved Malignant Breast Neoplasmto increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast canceropenfda
• Oct 29, 2025Denosumab FDA · US original application approved Malignant Breast Neoplasmto increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast canceropenfda
• Oct 29, 2025Denosumab FDA · US original application approved Malignant Prostate Neoplasmto increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate canceropenfda
• Oct 29, 2025Denosumab FDA · US original application approved Multiple MyelomaPrevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.openfda
• Oct 29, 2025Denosumab FDA · US original application approved Malignant Prostate Neoplasmto increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate canceropenfda
• Oct 23, 2025Belantamab Mafodotin FDA · US original application approved Multiple MyelomaBLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have…openfda
• Sep 25, 2025Imlunestrant FDA · US original application approved Malignant Breast NeoplasmINLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen…openfda
• Sep 9, 2025Gemcitabine FDA · US original application approved Non-Muscle Invasive Bladder CarcinomaINLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with…openfda
• Aug 29, 2025Denosumab FDA · US original application approved Multiple MyelomaPrevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.openfda
• Aug 8, 2025Carboplatin FDA · US original application approved Ovarian CarcinomaAs a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy.openfda
• Aug 8, 2025Zongertinib FDA · US original application accelerated approved Lung Non-Squamous Non-Small Cell CarcinomaHERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have…openfda
• Aug 8, 2025Carboplatin FDA · US original application approved Ovarian CarcinomaAs part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.openfda
• Aug 6, 2025Dordaviprone FDA · US original application accelerated approved Diffuse Midline GliomaMODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with…openfda
• Jul 3, 2025Bendamustine FDA · US original application approved Indolent B-Cell Non-Hodgkin LymphomaIndolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.openfda
• Jul 3, 2025Bendamustine FDA · US original application approved Chronic Lymphocytic LeukemiaChronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.openfda
• Jun 27, 2025Gemcitabine FDA · US original application approved Malignant Ovarian Neoplasmin combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.openfda
• Jun 27, 2025Gemcitabine FDA · US original application approved Malignant Breast Neoplasmin combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy,…openfda
• Jun 27, 2025Gemcitabine FDA · US original application approved Lung Non-Small Cell Carcinomain combination with cisplatin, for the treatment of non-small cell lung cancer.openfda
• Jun 27, 2025Gemcitabine FDA · US original application approved Malignant Pancreatic Neoplasmas a single agent for the treatment of pancreatic cancer.openfda
• Jun 12, 2025Mitomycin FDA · US original application approved Non-Muscle Invasive Bladder CarcinomaZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI…openfda
• Jun 11, 2025Taletrectinib FDA · US original application approved ROS1-Positive Lung Non-Small Cell CarcinomaIBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer…openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Mantle Cell LymphomaMantle cell lymphoma (MCL) who have received at least one prior therapy.openfda
• Jun 10, 2025Zanubrutinib FDA · US original application accelerated approved Waldenstrom MacroglobulinemiaThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Jun 10, 2025Zanubrutinib FDA · US original application accelerated approved Waldenstrom MacroglobulinemiaThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Marginal Zone LymphomaRelapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Marginal Zone LymphomaRelapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Follicular LymphomaRelapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Mantle Cell LymphomaMantle cell lymphoma (MCL) who have received at least one prior therapy.openfda
• Jun 10, 2025Zanubrutinib FDA · US original application approved Follicular LymphomaRelapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.openfda
• Mar 25, 2025Denosumab FDA · US original application approved Malignant Breast Neoplasmto increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast canceropenfda
• Mar 25, 2025Denosumab FDA · US original application approved Malignant Prostate Neoplasmto increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate canceropenfda
• Feb 19, 2025Nilotinib FDA · US original application approved Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 PositiveAdult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.openfda
• Feb 13, 2025Denosumab FDA · US original application approved Malignant Breast Neoplasmto increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast canceropenfda
• Feb 13, 2025Denosumab FDA · US original application approved Malignant Prostate Neoplasmto increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate canceropenfda
• Jan 21, 2025Treosulfan FDA · US original application approved Myelodysplastic Syndrome. Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of…openfda
• Jan 21, 2025Treosulfan FDA · US original application approved Acute Myeloid LeukemiaUse in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients…openfda
• Jan 17, 2025Datopotamab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmadult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC…openfda
• Jan 17, 2025Datopotamab Deruxtecan FDA · US original application approved Lung Non-Small Cell Carcinoma with EGFR Mutationadult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior…openfda
• Jan 17, 2025Datopotamab Deruxtecan FDA · US original application accelerated approved Triple-Negative Breast CarcinomaThis indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued…openfda
• Oct 29, 2025Denosumab FDA · US original application approved cancer not stated in this recordof postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for fracture • of…openfda
• Oct 29, 2025Denosumab FDA · US original application approved cancer not stated in this recordof postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for fracture • of…openfda
• Oct 29, 2025Denosumab FDA · US original application approved cancer not stated in this recordTreatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in…openfda
• Sep 10, 2025Selumetinib FDA · US original application approved cancer not stated in this recordKOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic,…openfda
• Aug 29, 2025Denosumab FDA · US original application approved cancer not stated in this recordTreatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in…openfda
• Jul 29, 2025Celecoxib FDA · US original application approved cancer not stated in this recordVYSCOXA contains celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated: In adults for • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) •…openfda
• Jun 10, 2025Zanubrutinib FDA · US original application accelerated approved cancer not stated in this recordThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Jun 10, 2025Zanubrutinib FDA · US original application accelerated approved cancer not stated in this recordThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Jun 5, 2025Meloxicam FDA · US original application approved cancer not stated in this recordXIFYRM is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Limitation of Use…openfda
• Apr 22, 2025Meloxicam FDA · US original application approved cancer not stated in this recordQAMZOVA is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Limitation of Use…openfda
• Mar 25, 2025Denosumab FDA · US original application approved cancer not stated in this recordof postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for fracture • of…openfda
• Feb 19, 2025Nilotinib FDA · US original application approved cancer not stated in this recordAdult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.openfda
• Feb 14, 2025Vimseltinib FDA · US original application approved cancer not stated in this recordROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause…openfda
• Feb 13, 2025Denosumab FDA · US original application approved cancer not stated in this recordof postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for fracture • of…openfda
• Sep 17, 2025Vorasidenib EMA · EU centralised approved Grade 2 Follicular LymphomaVoranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2…ema
• Jul 23, 2025Belantamab Mafodotin EMA · EU centralised approved Multiple MyelomaBlenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in patients who…ema
• Jul 18, 2025Inavolisib EMA · EU centralised approved Malignant Breast NeoplasmItovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor…ema
• Jul 17, 2025Obecabtagene Autoleucel EMA · EU centralised approved B Acute Lymphoblastic LeukemiaAucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic…ema
• Jun 27, 2025Zanidatamab EMA · EU centralised approved Malignant Biliary Tract NeoplasmZiihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer…ema

RegulatoryAll 2025 records with filters →

Studies

8,647

Interventional

6,409

Phase III

606

Industry-led

1,665

With posted results

26

Countries with sites

111

Published source: clinicaltrials · first_posted_date as posted