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 KRAS G12C-mutated, locally advanced or metastatic colorectal cancer previously treated with fluoropyrimidin-, oxaliplatin-, and irinotecan-based chemotherapy, randomized to sotorasib (960 mg daily) plus panitumumab (53 patients) or investigator's choice of standard-of-care chemotherapy (54 patients), in the analysis population supporting FDA approval within the phase 3 CodeBreaK 300 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 KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidin-, oxaliplatin-, and irinotecan-based chemotherapy.
Biomarker requirement
KRAS G12C mutation, as determined by an FDA-approved test
Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator's choice of therapy for KRAS G12C-mutated metastatic colorectal cancer (mCRC) (Journal of Clinical Oncology, ASCO Annual Meeting). DOI 10.1200/JCO.2024.42.17_suppl.LBA3510.
Adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy — a consolidation-therapy approval, not a first-line or newly-diagnosed LS-SCLC treatment broadly, and specifically the durvalumab-monotherapy regimen, not the durvalumab-plus-tremelimumab arm also tested in the same 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 LS-SCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, as consolidation therapy with durvalumab monotherapy.
Adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+ by central assessment) biliary tract cancer -- including cholangiocarcinoma and gallbladder cancer -- who had received prior gemcitabine-containing chemotherapy, enrolled in cohort 1 of the multicenter, single-arm, phase 2b HERIZON-BTC-01 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 previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test.
Biomarker requirement
HER2-positive (IHC 3+) by an FDA-approved companion diagnostic
Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study (The Lancet Oncology). DOI 10.1016/S1470-2045(23)00242-5, PMID 37276871.
Adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive, previously untreated, randomized to zolbetuximab plus chemotherapy or placebo plus chemotherapy (SPOTLIGHT trial population; a second, similarly-designed trial, GLOW, also supported this approval).
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
First-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
Biomarker requirement
CLDN18.2-positive by an FDA-approved companion diagnostic; HER2-negative
SPOTLIGHT trial primary results: zolbetuximab plus mFOLFOX6 in CLDN18.2-positive gastric/GEJ adenocarcinoma (The Lancet). DOI 10.1016/S0140-6736(23)00620-7, PMID 37068504.
Adults with endocrine-resistant, PIK3CA-mutated (as detected by an FDA-approved test), HR-positive, HER2-negative, locally advanced or metastatic breast cancer, whose disease recurred during or within 12 months of completing adjuvant endocrine therapy (or while still on adjuvant endocrine therapy after at least 2 years), with no prior systemic therapy for metastatic disease — used in combination with palbociclib and fulvestrant, never as a standalone drug.
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 endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with palbociclib and fulvestrant.
INAVO120 trial primary progression-free-survival results: inavolisib-based therapy in PIK3CA-mutated advanced breast cancer (NEJM). DOI 10.1056/NEJMoa2404625.
Average-risk adults ages 45 and older undergoing colorectal cancer screening, who provided a stool sample tested with both Cologuard Plus and a fecal immunochemical test (FIT), in the prospective, multicenter BLUE-C study.
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
Colorectal cancer screening in adults ages 45 and older at average risk of colorectal cancer.
Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (New England Journal of Medicine). DOI 10.1056/NEJMoa2310336, PMID 38477986.
Adults and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma carrying a susceptible IDH1 or IDH2 mutation, following surgery (biopsy, subtotal, or gross total resection), who had not yet received chemotherapy or radiotherapy — this does not apply to grade 3 or 4 IDH-mutant glioma, or to patients who have already received chemotherapy or radiation for their glioma.
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 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, subtotal resection, or gross total resection.
Adults (later reportedly expanded to include patients age 12 and older) with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumor is confirmed MAGE-A4-positive by an FDA-approved or cleared companion diagnostic — a genetically restricted population; only a minority of synovial sarcoma patients meet both the HLA and MAGE-A4 requirements. Efficacy reported here is from the 44-patient efficacy-evaluable analysis within a 52-patient enrolled cohort (SPEARHEAD-1 Cohort 1).
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 synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by an FDA-approved or cleared companion diagnostic device.
Biomarker requirement
HLA-A*02 (specific subtypes) and MAGE-A4 tumor expression
Decision date
2024-08-01
Access notes
Accelerated approval — continued approval was contingent on confirmatory trial data at the time of this approval.
Adults 30 to 70 years old with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in measurable-residual-disease-negative (MRD-negative) remission after induction and intensification chemotherapy, randomized to consolidation chemotherapy with or without blinatumomab. The FDA's broader approval also covers pediatric patients (1 month and older) and is not restricted to MRD-negative disease, supported by two additional pediatric relapse trials this record does not independently detail.
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 and pediatric patients 1 month and older with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia, in the consolidation phase of multiphase chemotherapy, regardless of measurable residual disease status.
Patients aged 2 to 20 with locally advanced or metastatic RET-altered solid tumors (including RET-altered thyroid cancer) that had not responded to available therapies, enrolled in the primary efficacy population of the international, single-arm, multicohort, phase 1/2 LIBRETTO-121 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
Pediatric patients aged 2 and older with RET-altered metastatic thyroid cancer, or other RET-altered solid tumors that are advanced or metastatic and require systemic therapy, that have progressed on or are intolerant to prior therapy, or for whom there is no satisfactory alternative treatment.
Safety and efficacy of selpercatinib in pediatric patients with RET-altered solid tumors: updated results from LIBRETTO-121 (Journal of Clinical Oncology, ASCO Annual Meeting). DOI 10.1200/JCO.2024.42.16_suppl.10022.
Applies to the exact indication stated.
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.