| 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 | 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 | 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 |
| 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 | 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 |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | 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 |
| 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 treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | May 22, 2023 | 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 | May 22, 2023 | openfda |
| 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 | May 22, 2023 | 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 | May 22, 2023 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: PEMRYDI RTU is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | May 22, 2023 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use : Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Jun 22, 2022 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Jun 22, 2022 | 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 22, 2022 | openfda |
| 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, non-small cell lung cancer (NSCLC). | approved | Jun 22, 2022 | 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 | May 26, 2022 | 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 | May 26, 2022 | openfda |
| 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 | May 26, 2022 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | May 26, 2022 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | May 26, 2022 | 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 | Aug 21, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Aug 21, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Aug 21, 2020 | openfda |
| 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 | Aug 21, 2020 | 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 | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy. | approved | Feb 8, 2020 | 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 NSCLC, with no EGFR or ALK genomic tumor aberrations. | approved | Feb 8, 2020 | openfda |
| 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, non-small cell lung cancer (NSCLC). | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Feb 4, 2004 | 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 | Feb 4, 2004 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Feb 4, 2004 | 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 | Feb 4, 2004 | openfda |
| 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 | Feb 4, 2004 | openfda |
| Porfimer | US FDA | Lung Non-Small Cell Carcinoma | Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus | approved | Dec 27, 1995 | openfda |
| Pralsetinib | EU EMA | Lung Non-Small Cell Carcinoma | Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.conditional | withdrawnsince Oct 24, 2024 | Nov 18, 2021 | ema |
| Pralsetinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). | approved | Sep 4, 2020 | openfda |
| Ramucirumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. | approved | Apr 21, 2014 | openfda |
| Ramucirumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease 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 CYRAMZA. | approved | Apr 21, 2014 | openfda |
| Repotrectinib | EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)conditional | approved | Jan 13, 2025 | ema |
| Repotrectinib | US FDA | Tumor-agnostic | adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved | Nov 15, 2023 | openfda |
| Repotrectinib | US FDA | ROS1-Positive Lung Non-Small Cell Carcinoma | AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). | approved | Nov 15, 2023 | openfda |
| Selpercatinib | EU EMA | Tumor-agnostic | Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2. | approved | Feb 11, 2021 | ema |
| Selpercatinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test | approved | Apr 10, 2024 | openfda |