| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Aug 28, 2015 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. | approved | Aug 28, 2015 | openfda |
| Erlotinib Hydrochloride | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Nov 5, 2019 | openfda |
| Erlotinib Hydrochloride | US FDA | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen | approved | Nov 5, 2019 | openfda |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK. | withdrawnsince Sep 27, 2024 | Sep 27, 2018 | ema |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase. | approved | Jun 24, 2009 | ema |
| Gefitinib | US FDA | Lung Non-Small Cell Carcinoma | IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (1) Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1) | approved | Jul 13, 2015 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin, for the treatment of non-small cell lung cancer. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 4, 2011 | openfda |
| Ipilimumab | US FDA | Lung Non-Small Cell Carcinoma | Treatment of 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 nivolumab and 2 cycles of platinum-doublet chemotherapy. | approved | Mar 25, 2011 | openfda |
| Ipilimumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • Treatment of 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 nivolumab. | approved | Mar 25, 2011 | openfda |
| Larotrectinib | EU EMA | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.conditional | approved | Sep 19, 2019 | ema |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Lazertinib | EU EMA | Lung Non-Small Cell Carcinoma | Lazcluze in combination with amivantamab is indicated 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. | approved | Jan 20, 2025 | ema |
| Lazertinib | US FDA | Lung Non-Small Cell Carcinoma | LAZCLUZE, in combination with amivantamab, 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 (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab 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. ( 1 ) | approved | Aug 19, 2024 | openfda |
| Lorlatinib | EU EMA | Lung Non-Small Cell Carcinoma | Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK?positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI. | approved | May 6, 2019 | ema |
| Necitumumab | EU EMA | Lung Non-Small Cell Carcinoma | Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. | withdrawn | Feb 15, 2016 | ema |
| 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 | 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 | 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 | 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 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 |
| 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 |
| 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 | 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 | 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 |
| 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 | 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 |
| Pembrolizumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. | 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 | Lung Non-Small Cell Carcinoma | as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Lung Non-Small Cell Carcinoma | as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Lung Non-Small Cell Carcinoma | as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Tumor-agnostic | for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. • Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. • Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. • in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. • in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. • for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. • Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 • Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. • Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. • 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. | approved | Jun 28, 2024 | openfda |