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 muscle-invasive bladder cancer (MIBC) who had radical cystectomy with lymph node dissection and had detectable circulating tumor DNA (ctDNA) molecular residual disease (MRD) on serial blood testing within 12 months of surgery, randomized to atezolizumab or placebo, in the randomized, double-blind, phase 3 IMvigor011 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 muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease, as determined by an FDA-authorized test.
Biomarker requirement
Circulating tumor DNA (ctDNA) molecular residual disease, as determined by Signatera CDx
Adjuvant Atezolizumab Guided by Circulating Tumor DNA in Muscle-Invasive Bladder Cancer (New England Journal of Medicine). DOI 10.1056/NEJMoa2511885, PMID 41124204.
Adults 75 years or older, or with comorbidities precluding intensive induction chemotherapy, with newly diagnosed acute myeloid leukemia (AML), enrolled in the single-arm, open-label Study ASTX727-07.
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 newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Fully Oral Combination of Decitabine/Cedazuridine (ASTX727) Plus Venetoclax for the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Patients Ineligible for Intensive Chemotherapy (Blood, ASH Annual Meeting). DOI 10.1182/blood-2024-198541.
Adults with locally advanced pancreatic adenocarcinoma, randomized to Tumor Treating Fields (TTFields) plus gemcitabine/nab-paclitaxel chemotherapy or chemotherapy alone, in the randomized, open-label, phase 3 PANOVA-3 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 locally advanced pancreatic cancer, used concomitantly with gemcitabine and nab-paclitaxel.
Decision date
2026-02-11
Access notes
A DEVICE approval, not a drug approval -- disclosed as such, not conflated with a pharmaceutical regulatory action.
Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study (Journal of Clinical Oncology). DOI 10.1200/JCO-25-00746.
Adults with platinum-resistant, PD-L1-positive (CPS >=1) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had received one to two prior lines of systemic therapy, randomized to pembrolizumab plus paclitaxel (+/- bevacizumab) or placebo plus paclitaxel (+/- bevacizumab), in the randomized, double-blind, phase 3 ENGOT-ov65/KEYNOTE-B96 trial conducted at 187 sites in 25 countries.
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 platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >=1), who have received one to two prior lines of systemic therapy.
Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study (The Lancet). DOI 10.1016/S0140-6736(26)00602-1, PMID 41974150.
Adults with relapsed or refractory marginal zone lymphoma (MZL) who had received at least 2 lines of prior systemic therapy (including an anti-CD20 antibody and an alkylating agent) or who relapsed after stem cell transplantation, enrolled in the MZL cohort of the open-label, single-arm, phase 2 TRANSCEND FL 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 marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.
Biomarker requirement
CD19-expressing B-cell lymphoma (target of the CAR T-cell construct; not a patient-selection biomarker test)
Adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor, randomized to pirtobrutinib or investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab, in the randomized, open-label, phase 3 BRUIN-CLL-321 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 CLL/SLL who have previously been treated with a covalent BTK inhibitor.
Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321) (Journal of Clinical Oncology). DOI 10.1200/JCO-25-00166, PMID 40479620.
Adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy (with or without an anti-PD-(L)1 agent), randomized to tarlatamab or investigator's choice of chemotherapy, in the phase 3 DeLLphi-304 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 extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Biomarker requirement
DLL3-expressing small cell lung cancer (target of the bispecific antibody; not a patient-selection biomarker test)
Adults with stage III-IVA resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, randomized to perioperative pembrolizumab (before and after surgery) plus standard of care, or standard of care alone, at 192 sites in North America, South America, and Europe, in the phase 3 KEYNOTE-689 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 resectable, locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS >=1), as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (with or without cisplatin), then as a single agent.
Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer (New England Journal of Medicine). DOI 10.1056/NEJMoa2415434, PMID 40532178.
More than 9,200 prostate core needle biopsy cases (>122,000 slides) reviewed at a CLIA-certified precision pathology laboratory over a 3-year period, assisted by the Galen(TM) Prostate AI second-read system (the same underlying technology later cleared as Ibex Prostate Detect), in real-world institutional validation work.
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
Software-only in vitro diagnostic device intended to assist pathologists in the detection of prostatic cancer on digitized whole-slide images of prostate core needle biopsies.
Decision date
2025-02-10
Access notes
A 510(k) CLEARANCE, not a full premarket approval -- disclosed as such, not conflated with a drug approval.
Validation and three years of clinical experience in using an artificial intelligence algorithm as a second read system for prostate cancer diagnosis -- real-world experience (Modern Pathology). PMID 38868487.
HR-positive, HER2-low or HER2-ultralow, unresectable or metastatic breast cancer, after progression on endocrine therapy — this exact scope must not be broadened.
View approval details
Last reviewed
2026-08-11
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
HR-positive, HER2-low or HER2-ultralow unresectable/metastatic breast cancer that progressed on one or more endocrine therapies in the metastatic setting.
FDA-approved indication expansion; DESTINY-Breast06 (NEJM). DOI 10.1056/NEJMoa2407086, PMID 39282896.
Applies to the exact indication stated.
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