| Abiraterone | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. | approved | Apr 26, 2021 | ema |
| Abiraterone | EU EMA | Castration-Resistant Prostate Carcinoma | Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.accelerated | approved | Sep 5, 2011 | ema |
| Abiraterone | US FDA | Castration-Resistant Prostate Carcinoma | Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) | approved | May 22, 2018 | openfda |
| Abiraterone Acetate | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. | approved | Aug 20, 2021 | ema |
| Abiraterone Acetate | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. | approved | Jun 24, 2021 | ema |
| Abiraterone Acetate | US FDA | Castration-Resistant Prostate Carcinoma | Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) | approved | May 22, 2018 | openfda |
| Adagrasib | EU EMA | Lung Non-Small Cell Carcinoma | Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.conditional | approved | Jan 5, 2024 | ema |
| Adagrasib | US FDA | Lung Non-Small Cell Carcinoma | Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. | approved | Dec 12, 2022 | openfda |
| Afatinib | EU EMA | Lung Non-Small Cell Carcinoma | Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. | approved | Sep 25, 2013 | ema |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test | approved | Jul 12, 2013 | openfda |
| Aldesleukin | US FDA | Renal Cell Carcinoma | The treatment of adults with metastatic renal cell carcinoma. | approved | May 5, 1992 | openfda |
| Alectinib | EU EMA | ALK-Positive Lung Non-Small Cell Carcinoma | Adjuvant treatment of resected non small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).Treatment of advanced NSCLCAlecensa as monotherapy is indicated for the first line treatment of adult patients with ALK positive advanced NSCLC.Alecensa as monotherapy is indicated for the treatment of adult patients with ALK positive advanced NSCLC previously treated with crizotinib. | approved | Feb 16, 2017 | ema |
| Alectinib | US FDA | Lung Non-Small Cell Carcinoma | treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. | approved | Dec 11, 2015 | openfda |
| Amivantamab | EU EMA | Lung Non-Small Cell Carcinoma | Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy. | approved | Dec 9, 2021 | ema |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy. | approved | May 21, 2021 | openfda |
| Apalutamide | EU EMA | Nonmetastatic Castration-Resistant Prostate Carcinoma | Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). | approved | Jan 14, 2019 | ema |
| Apalutamide | US FDA | Nonmetastatic Castration-Resistant Prostate Carcinoma | ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 ) | approved | Feb 14, 2018 | openfda |
| Atezolizumab | US FDA | Lung Small Cell Carcinoma | in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Small Cell Carcinoma | Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. | approved | May 18, 2016 | openfda |
| Aumolertinib | EU EMA | Lung Non-Small Cell Carcinoma | Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2) | approved | Feb 12, 2026 | ema |
| Avelumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC. | approved | Mar 23, 2017 | openfda |
| Avelumab | US FDA | Urothelial Carcinoma | Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. | approved | Mar 23, 2017 | openfda |
| Avelumab | US FDA | Merkel Cell Carcinoma | Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. | approved | Mar 23, 2017 | openfda |
| Axitinib | EU EMA | Renal Cell Carcinoma | Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. | approved | Sep 19, 2024 | ema |
| Axitinib | EU EMA | Renal Cell Carcinoma | Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. | approved | Sep 3, 2012 | ema |
| Axitinib | US FDA | Renal Cell Carcinoma | as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). | approved | Jan 27, 2012 | openfda |
| Belzutifan | US FDA | Clear Cell Renal Cell Carcinoma | as monotherapy, for treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). | approved | Aug 13, 2021 | openfda |
| Belzutifan | US FDA | Clear Cell Renal Cell Carcinoma | Renal Cell Carcinoma with a Clear Cell Component (ccRCC) in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the adjuvant treatment of adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. | approved | Aug 13, 2021 | openfda |
| Bevacizumab | US FDA | Renal Cell Carcinoma | Metastatic renal cell carcinoma in combination with interferon alfa. | approved | Feb 26, 2004 | openfda |
| Bevacizumab | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. | approved | Feb 26, 2004 | openfda |
| Bevacizumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) in combination with atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy | approved | Feb 26, 2004 | openfda |
| Bicalutamide | US FDA | Prostate Carcinoma | 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1) | approved | Oct 4, 1995 | openfda |
| Binimetinib | US FDA | Lung Non-Small Cell Carcinoma | in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. | approved | Jun 27, 2018 | openfda |
| Cabazitaxel | US FDA | Castration-Resistant Prostate Carcinoma | JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 ) | approved | Jun 17, 2010 | openfda |
| Cabozantinib | EU EMA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.accelerated | approved | Sep 9, 2016 | ema |
| Cabozantinib | EU EMA | Thyroid Gland Medullary Carcinoma | Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. | approved | Mar 21, 2014 | ema |
| Cabozantinib | US FDA | Hepatocellular Carcinoma | patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Renal Cell Carcinoma | patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Renal Cell Carcinoma | CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). | approved | Apr 25, 2016 | openfda |