| Fulvestrant | US FDA | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: | approved | Apr 25, 2002 | openfda |
| Fulvestrant | US FDA | Malignant Breast Neoplasm | HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) | approved | Apr 25, 2002 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Aug 4, 2011 | openfda |
| Goserelin | US FDA | Malignant Breast Neoplasm | Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women | approved | Dec 29, 1989 | openfda |
| Imlunestrant | US FDA | Malignant Breast Neoplasm | INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 ) | approved | Sep 25, 2025 | openfda |
| Inavolisib | US FDA | Malignant Breast Neoplasm | ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 ) | approved | Oct 10, 2024 | openfda |
| Lapatinib | US FDA | Malignant Breast Neoplasm | TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. | approved | Mar 13, 2007 | 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 |
| 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 |
| Letrozole | US FDA | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. | approved | Jul 25, 1997 | openfda |
| Letrozole | US FDA | Malignant Breast Neoplasm | First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. | approved | Jul 25, 1997 | openfda |
| Letrozole | US FDA | Malignant Breast Neoplasm | Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. | approved | Jul 25, 1997 | openfda |
| Margetuximab | US FDA | HER2-Positive Breast Carcinoma | MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 ) | approved | Dec 16, 2020 | openfda |
| Megestrol | US FDA | Breast Carcinoma | Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. | approved | Aug 8, 1988 | openfda |
| Methotrexate | US FDA | Malignant Breast Neoplasm | o Treatment of adults with breast cancer as part of a combination chemotherapy regimen. | approved | Aug 10, 1959 | openfda |
| Neratinib | US FDA | HER2-Positive Breast Carcinoma | As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. | approved | Jul 17, 2017 | openfda |
| 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 |
| Olaparib | US FDA | Malignant Breast Neoplasm | Breast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. 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 |
| Paclitaxel | US FDA | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | approved | May 11, 2023 | openfda |
| Paclitaxel | US FDA | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | approved | Jul 27, 2022 | openfda |
| Paclitaxel | US FDA | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | approved | Jan 7, 2005 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2‑positive locally advanced or metastatic breast cancer following induction treatment. | approved | Nov 1, 2019 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy | approved | Nov 1, 2019 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following recurrence on or after completing adjuvant endocrine therapy. | approved | Nov 1, 2019 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2 positive locally advanced or metastatic breast cancer following induction treatment. | approved | Feb 3, 2015 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy. | approved | Feb 3, 2015 | openfda |
| Palbociclib | US FDA | Malignant Breast Neoplasm | for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy | approved | Feb 3, 2015 | 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 | 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 | Triple-Negative Breast Carcinoma | in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable 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 | 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 |
| Pertuzumab | US FDA | Malignant Breast Neoplasm | Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. | approved | Jun 8, 2012 | openfda |
| Pertuzumab | US FDA | Early Stage Breast Carcinoma | Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. | approved | Jun 8, 2012 | openfda |
| Pertuzumab | US FDA | Malignant Breast Neoplasm | adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence | approved | Jun 8, 2012 | openfda |
| 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 |
| Ribociclib | US FDA | Malignant Breast Neoplasm | Advanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. | approved | Mar 13, 2017 | openfda |
| Ribociclib | US FDA | Malignant Breast Neoplasm | Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. | approved | Mar 13, 2017 | openfda |
| Sacituzumab Govitecan | US FDA | Triple-Negative Breast Carcinoma | Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. | approved | Apr 22, 2020 | openfda |
| Sacituzumab Govitecan | US FDA | Triple-Negative Breast Carcinoma | In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph 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 | Apr 22, 2020 | openfda |
| Sacituzumab Govitecan | US FDA | Malignant Breast Neoplasm | Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer For the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. | approved | Apr 22, 2020 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | Apr 10, 2024 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | May 8, 2020 | openfda |
| Talazoparib | US FDA | Malignant Breast Neoplasm | Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. | approved | Mar 7, 2024 | openfda |
| Talazoparib | US FDA | Malignant Breast Neoplasm | Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. | approved | Oct 16, 2018 | openfda |
| Tamoxifen | US FDA | Malignant Breast Neoplasm | To reduce the incidence of breast cancer in adult women at high risk | approved | Oct 29, 2005 | openfda |
| Tamoxifen | US FDA | Malignant Breast Neoplasm | For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer | approved | Oct 29, 2005 | openfda |
| Tamoxifen | US FDA | Malignant Breast Neoplasm | For treatment of adult patients with estrogen receptor-positive metastatic breast cancer | approved | Oct 29, 2005 | openfda |