| Neratinib | US FDA | HER2-Positive Breast Carcinoma | In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. | approved | Jul 17, 2017 | openfda |
| Nintedanib | EU EMA | Lung Non-Small Cell Carcinoma | Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy. | approved | Nov 21, 2014 | ema |
| Nivolumab | EU EMA | Lung Non-Small Cell Carcinoma | Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. | withdrawnsince Nov 30, 2015 | Jul 20, 2015 | ema |
| Nivolumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | Urothelial Carcinoma • adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Renal Cell Carcinoma | adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Renal Cell Carcinoma | adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | dMMR Colorectal Carcinoma | Colorectal Cancer • adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Head and Neck Squamous Cell Carcinoma | autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nogapendekin Alfa Inbakicept | EU EMA | Non-Muscle Invasive Bladder Carcinoma | Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.conditional | approved | Feb 16, 2026 | ema |
| Nogapendekin Alfa Inbakicept | US FDA | Non-Muscle Invasive Bladder Carcinoma | ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 ) | approved | Apr 22, 2024 | openfda |
| Olaparib | US FDA | Castration-Resistant Prostate Carcinoma | Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Hormone Receptor-Positive Breast Carcinoma | for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Pancreatic Adenocarcinoma | Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Castration-Resistant Prostate Carcinoma | in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Osimertinib | EU EMA | Lung Non-Small Cell Carcinoma | Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.accelerated | approved | Feb 1, 2016 | ema |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | May 11, 2023 | openfda |
| Paclitaxel | US FDA | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. | approved | May 11, 2023 | openfda |
| Paclitaxel | US FDA | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. | approved | Jul 27, 2022 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | Jul 27, 2022 | openfda |
| Paclitaxel | US FDA | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. | approved | Jan 7, 2005 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | Jan 7, 2005 | openfda |
| Padeliporfin | EU EMA | Prostate Adenocarcinoma | Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³. | approved | Nov 10, 2017 | ema |
| Pazopanib | US FDA | Renal Cell Carcinoma | advanced renal cell carcinoma (RCC). | approved | Oct 19, 2009 | openfda |
| Pembrolizumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Triple-Negative Breast Carcinoma | Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Triple-Negative Breast Carcinoma | in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Lung Non-Small Cell Carcinoma | for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Head and Neck Squamous Cell Carcinoma | as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test. | approved | Sep 4, 2014 | openfda |