United States FDA approvals only. Each is an approval for the exact stated cancer and use, shown separately from evidence certainty and guideline position.
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28 verified FDA-approval stories match your filters.
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens (including chemotherapy, with or without bevacizumab or an anti-PD-(L)1 agent), randomized to tisotumab vedotin or investigator's choice of chemotherapy.
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Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
innovaTV 301/ENGOT-cx12/GOG-3057 trial results: tisotumab vedotin versus chemotherapy in recurrent or metastatic cervical cancer (Annals of Oncology). DOI 10.1016/j.annonc.2023.10.029.
Patients 6 months to 25 years old with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation, who had received at least one prior systemic therapy, enrolled in the single-arm, open-label FIREFLY-1 trial.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation.
Adults with unresectable or metastatic melanoma previously treated with a PD-1-blocking antibody and, if BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor, given a one-time infusion of lifileucel. The FDA's accelerated approval rested specifically on the 73-patient efficacy-evaluable subset of cohort 4 in the single-arm, open-label, multicohort C-144-01 trial; a separately published pooled analysis combining cohorts 2 and 4 (153 patients total) reported a consistent objective response rate.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with unresectable or metastatic melanoma previously treated with a PD-1-blocking antibody and, if BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor.
Decision date
2024-02-16
Access notes
Requires specialized, REMS-certified treatment centers due to the manufacturing and lymphodepleting-chemotherapy process involved.
Efficacy and safety of lifileucel, a one-time autologous TIL cell therapy, in patients with advanced melanoma: pooled analysis of consecutive cohorts of the C-144-01 study (Journal for ImmunoTherapy of Cancer). DOI 10.1136/jitc-2022-005755, PMID 36600653.
Adult and pediatric patients with high-risk neuroblastoma (a cancer arising from immature nerve cells, most common in young children) who showed at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy, enrolled in the single-arm Study 3b and compared against an external control group drawn from a separate NCI/Children's Oncology Group trial (Study ANBL0032).
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy, to reduce the risk of relapse.
US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy (Journal of Clinical Oncology). DOI 10.1200/JCO.24.00546, PMID 38917371.
Adults with relapsed or refractory multiple myeloma who had already received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, enrolled in the single-arm, open-label MonumenTAL-1 trial.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Biomarker requirement
GPRC5D-expressing multiple myeloma (target of the bispecific antibody; not a patient-selection biomarker test)
Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or other large B-cell lymphoma after two or more prior lines of systemic therapy, enrolled in the dose-expansion cohort of the single-arm, open-label, phase 1/2 EPCORE NHL-1 trial.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) and high-grade B-cell lymphoma, after two or more lines of systemic therapy.
Biomarker requirement
CD20-expressing B-cell lymphoma (target of the bispecific antibody; not a patient-selection biomarker test)
Decision date
2023-05-19
Access notes
Requires a step-up dosing schedule and monitoring for cytokine release syndrome, particularly around the first doses.
Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial (Journal of Clinical Oncology). DOI 10.1200/JCO.22.01725, PMID 36548927.
Adults with germline BRCA1- or BRCA2-mutated, HER2-negative, high-risk early breast cancer, following completion of local treatment and (neo)adjuvant chemotherapy, randomized to one year of adjuvant olaparib or placebo.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Women aged 20-29 in England, tracked via national population-based cervical cancer mortality data from 2001 to 2024, spanning cohorts vaccinated and not vaccinated under England's HPV immunisation program (introduced 2008).
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Prevention of cervical, vulvar, vaginal, and anal cancers and precancerous/dysplastic lesions caused by specific HPV types (Gardasil 9's original approved indication) -- cited as evidence the underlying vaccine family is licensed and non-investigational, NOT as an FDA review of the England mortality analysis this record reports.
Decision date
2014-12-10
Access notes
Cited for regulatory-status context only -- this record's actual claims are about a separate, later England-specific mortality analysis, not this original US approval.
Cervical cancer mortality trends following HPV vaccination in England, 2001-24: an analysis of population-based mortality data (The Lancet). DOI 10.1016/S0140-6736(26)00918-9.
Applies to the exact indication stated.
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