| Docetaxel | US FDA | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Malignant Breast Neoplasm | Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2010-05-13 (see label) | approved | May 13, 2010 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2007-09-28 (see label) | approved | Sep 28, 2007 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2006-10-17 (see label) | approved | Oct 17, 2006 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2006-03-22 (see label) | approved | Mar 22, 2006 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2004-08-18 (see label) | approved | Aug 18, 2004 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2004-05-19 (see label) | approved | May 19, 2004 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 2002-11-27 (see label) | approved | Nov 27, 2002 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 1999-12-23 (see label) | approved | Dec 23, 1999 | openfda |
| Docetaxel | US FDA | — | Efficacy supplement 1998-06-22 (see label) | approved | Jun 22, 1998 | openfda |
| Docetaxel | US FDA | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Malignant Breast Neoplasm | Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | approved | May 14, 1996 | 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 | Nov 9, 2020 | openfda |
| 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 | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | approved | Nov 9, 2020 | 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 | US FDA | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | approved | Aug 28, 2015 | openfda |
| 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 | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | approved | Aug 28, 2015 | openfda |
| 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 |
| Melphalan | US FDA | Multiple Myeloma | Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 ) | approved | Aug 18, 2023 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. | approved | Jun 9, 2009 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2017-06-29 (see label) | approved | Jun 29, 2017 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2008-06-23 (see label) | approved | Jun 23, 2008 | openfda |
| Panitumumab | US FDA | Malignant Colorectal Neoplasm | Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1 , 14.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)* In combination with sotorasib, for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1 ) *Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown ( 1 , 2.1 , 5.2 , 12.1 , 14.3 ). Metastatic Colorectal Cancer (mCRC) RAS Wild-Type mCRC Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC) [see Dosage and Administration (2.1) ] : As first-line therapy in combination with FOLFOX [see Clinical Studies (14.2) ] . As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see Clinical Studies (14.1) ] . KRAS G12C -mutated mCRC Vectibix, in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.4) ] . Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] . | approved | Sep 27, 2006 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2025-11-19 (see label) | approved | Nov 19, 2025 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2025-09-10 (see label) | approved | Sep 10, 2025 | openfda |
| Selumetinib | US FDA | — | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ) | approved | Sep 10, 2025 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2024-01-24 (see label) | approved | Jan 24, 2024 | openfda |
| Selumetinib | US FDA | — | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ) | approved | Apr 10, 2020 | openfda |
| Sotorasib | US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| Sotorasib | US FDA | Malignant Colorectal Neoplasm | KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. | approved | May 28, 2021 | openfda |
| Sotorasib | US FDA | Lung Non-Small Cell Carcinoma | KRAS G12C-mutated Locally Advanced or Metastatic 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 | May 28, 2021 | openfda |
| Sotorasib | US FDA | — | This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).accelerated | approved | May 28, 2021 | openfda |