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Micromedex® Compendia Resources

Through the process established by the Centers for Medicare and Medicaid Services (CMS), Micromedex® DRUGDEX® is recognized by CMS as a compendium for the determination of payment for medically-accepted off-label uses for anti-cancer regimens. Effective January 1, 2010, new requirements were implemented that include a provision for providing transparency of processes used to evaluate therapies and to identify potential conflicts of interest. Specifically, publishers of compendia must now make the following information available via their public websites:

- Criteria used to evaluate the request (therapy)

- Disclosure of evidence considered

- Meeting minutes and records of votes for disposition of the request (therapy)

- Names of individuals who have substantively participated in the development of the compendia recommendations and disclosure of any potential conflicts of interest

To meet these requirements, documents detailing this information for each drug/off-label use pair published on or after January 1, 2010 are posted below. Information is organized by drug name, with the document title indicating the off-label use. Further transparency regarding Micromedex Off-Label processes can be found in the Micromedex Compendia Uses Policy.

Micromedex® Compendia Policy

This document outlines the policy and procedures employed by Micromedex® Editorial teams to identify clinically relevant off-label uses for FDA-approved medications and develop evidence-based content for inclusion in Micromedex content sets to support the designation of DRUGDEX® as a named compendium for the CMS. 3 pages

Micromedex® Off-label Request Process

This document outlines the process by which external parties may submit a request for a new off-label use to be evaluated for inclusion in Micromedex DRUGDEX®. Any consideration will be done independently by Micromedex editorial staff following existing policies to maintain objectivity and editorial independence. 2 pages

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Explore the Micromedex capabilities and features that provide comprehensive clinical decision support for clinicians at the point of care.

Abemaciclib

Breast cancer; Early, hormone receptor-positive, HER2-negative, node-positive, high-risk, in combination with adjuvant endocrine therapy

Malignant tumor of breast; Metastatic, HER2-negative, hormone receptor-positive, in combination with fulvestrant as initial endocrine-based therapy

Abiraterone Acetate

Hormone sensitive prostate cancer, newly diagnosed, Metastatic, high-risk, in combination with prednisone and androgen-deprivation therapy

Malignant tumor of prostate; Nonmetastatic, high-risk, in combination with androgen deprivation therapy

Acalabrutinib

Waldenström macroglobulinemia

Acitretin

Prophylaxis of skin cancers, in high-risk renal transplant recipients

Adagrasib

Malignant tumor of pancreas Unresectable or metastatic, KRAS G12C-mutated, in patients who have received at least 1 prior systemic therapy

Ado-Trastuzumab Emtansine

Malignant tumor of breast; Advanced or metastatic, HER2-positive, first-line therapy

Non-small cell lung cancer; Advanced disease, previously treated, HER2 mutation-positive

Afatinib Dimaleate

Squamous cell carcinoma of the head and neck, Recurrent and/or metastatic disease, second-line as monotherapy after failure of platinum-based therapy

Alemtuzumab

Chronic lymphocytic leukemia

Graft versus host disease, in patients receiving allogeneic stem cell transplant for hematologic malignancies, steroid-refractory

(PEDIATRIC) Graft versus host disease, in patients receiving allogeneic stem cell transplant for hematologic malignancies, steroid-refractory

Primary cutaneous T-cell lymphoma, Relapsed or refractory

Anastrozole

Intraductal carcinoma in situ of breast, as adjuvant therapy in postmenopausal women with hormone receptor-positive disease

Malignant tumor of ovary; Recurrent, estrogen- or progesterone-receptor positive, in postmenopausal women

Prevention of breast cancer in postmenopausal women at high risk

Antithymocyte globulin equine

Myelodysplastic syndrome

Antithymocyte Globulin Rabbit

Graft versus host disease, prophylaxis in patients receiving unrelated donor hematopoietic stem cell transplantation for hematologic malignancies

Apixaban

Thromboembolism of vein, Prophylaxis; In high-risk outpatients, Malignant neoplastic disease

Thromboembolism of vein; Malignant neoplastic disease

Arsenic Trioxide

Acute promyelocytic leukemia, FAB M3 newly diagnosed, low to intermediate risk, in combination with all-trans retinoic acid

Asparaginase Escherichia Coli

Extranodal NK/T-cell lymphoma, nasal type

Atezolizumab

Non-small cell lung cancer, advanced disease, 2nd or 3rd line after failure of platinum-based chemotherapy

Renal cell carcinoma Adjuvant treatment, in patients at increased risk of recurrence following nephrectomy

Axitinib

Renal cell carcinoma, Adjuvant therapy following nephrectomy in patients at high risk for recurrence

Metastatic renal cell carcinoma, first-line therapy

Bendamustine Hydrochloride

Waldenström macroglobulinemia; In combination with rituximab

Mantle cell lymphoma; Previously untreated, transplant ineligible, in combination with rituximab

Metastatic breast cancer

AL amyloidosis; Relapsed or refractory, combination therapy with dexamethasone

Non-Hodgkin's lymphoma (clinical); Large B-cell, relapsed or refractory, as lymphodepleting chemotherapy prior to tisagenlecleucel

Bevacizumab

Nonsquamous nonsmall cell neoplasm of lung, stage IIIB/IV or recurrent disease with EGFR exon 19 deletion or exon 21 mutation, first-line therapy in combination with erlotinib

Nonsquamous nonsmall cell neoplasm of lung Stage IIIB/IV, first-line therapy in combination with pemetrexed and carboplatin

Necrosis of central nervous system due to exposure to ionizing radiation

Extensive stage small cell lung cancer, First-line, in combination with chemotherapy

Nonsquamous nonsmall cell neoplasm of lung; Stage IIIB/IV, continuation maintenance therapy as a single-agent following platinum-based, first-line therapy

Cancer of cervix, recurrent, persistent, or metastatic

Colon cancer, adjuvant therapy in combination with fluorouracil, leucovorin, and oxaliplatin

Gastric cancer, advanced, first-line therapy in combination with fluoropyrimidine-based chemotherapy

Glioblastoma multiforme of brain, newly diagnosed

Liver carcinoma, advanced

Metastatic breast cancer, HER2-negative, first-line therapy in combination with chemotherapy (except paclitaxel)

Metastatic breast cancer, HER2-negative, as second-line therapy in combination with other chemotherapy

Nonsquamous non-small cell lung cancer, advanced or recurrent, first-line therapy in combination with cisplatin and gemcitabine

Ovarian cancer, advanced, first-line therapy in combination with carboplatin and paclitaxel

Malignant neoplasm of endometrium of corpus uteri – Advanced or recurrent

Binimetinib

Malignant tumor of ovary Fallopian tube, or primary peritoneal cancer, low-grade serous carcinoma, recurrent or persistent disease, as monotherapy

Bortezomib

Amyloid light chain amyloidosis

Thrombotic thrombocytopenic purpura Relapsed or refractory

Brentuximab vedotin

Hodgkin’s disease (clinical); Relapsed or refractory (PEDIATRIC)

Hodgkin lymphoma, consolidation therapy after autologous stem-cell transplantation

Cabozantinib malate

Renal cell cancer, Advanced, after failure of prior antiangiogenic therapy

Capecitabine

Metastatic colorectal cancer, maintenance therapy following oxaliplatin-based induction chemotherapy in previously untreated patients

Malignant tumor of breast; Early, HER2-negative, postoperative monotherapy in patients with residual disease after neoadjuvant anthracycline/taxane-based treatment

Triple-negative breast cancer; Early, adjuvant therapy

Gastric cancer, stage ll to lllB, adjuvant therapy in combination with oxaliplatin

Rectal cancer, locally advanced, adjuvant or neoadjuvant therapy, in combination with radiotherapy

Stage lll colon cancer, adjuvant, in combination with oxaliplatin

Carboplatin

Triple negative breast cancer, neoadjuvant, in combination with chemotherapy

Metastatic breast cancer, HER2 overexpression, first-line therapy in combination with a taxane and trastuzumab

Ovarian cancer, early-stage epithelial, adjuvant therapy

Testicular seminoma, stage 1, adjuvant, monotherapy

Carfilzomib

Multiple myeloma; Newly diagnosed, transplant-eligible, in combination with an immunomodulatory drug and a steroid

Multiple myeloma; Newly diagnosed, transplant-ineligible, in combination with a chemotherapy agent and a steroid

Waldenstrom macroglobulinemia

Celecoxib

Prevention of sporadic colorectal adenomas, in high-risk patients

Ceritinib

Non-small cell lung cancer ROS1-rearrangement, locally advanced or metastatic, in patients previously treated with non-targeted standard therapy

Cetuximab

Gastric or gastroesophageal junction cancer, advanced, as first-line therapy in combination with fluoropyrimidine-based chemotherapy

Cidofovir

Vulval intraepithelial neoplasia (VIN); High-grade, squamous

Cisplatin

Malignant tumor of urinary bladder, Muscle invasive, as neoadjuvant combination chemotherapy

Malignant tumor of thyroid gland, Advanced, in combination with doxorubicin

Non-Hodgkin lymphoma, Relapsed or refractory, as part of the DHAP or ESHAP chemotherapy regimen

Pancreatic cancer, locally advanced or metastatic, first-line therapy in combination with gemcitabine

Triple negative breast cancer

Cladribine

Acute myeloid leukemia, disease; Induction therapy

Systemic mastocytosis

Cyclophosphamide

Graft versus host disease, Prophylaxis, As monotherapy in patients who have received matched related or unrelated bone marrow transplantation for high risk hematologic malignancies with a myeloablative conditioning regimen

Dabrafenib Mesylate

Non-small cell lung cancer, metastatic with BRAF V600E mutation, in previously treated patients as monotherapy or in combination with trametinib

Malignant melanoma, Adjuvant, following complete resection of Stage III (with lymph node involvement greater than 1 mm) disease with BRAF V600E or V600K mutation, in combination with trametinib

Dalteparin

Thromboembolism of vein - Prophylaxis; In high-risk outpatients, Malignant neoplastic disease

Daratumumab

AL amyloidosis - Relapsed or refractory

Dasatinib

Philadelphia chromosome-positive acute lymphoblastic leukemia; Newly diagnosed, in combination with chemotherapy

Chronic phase chronic myeloid leukemia, Philadelphia chromosome-positive, newly diagnosed

Defibrotide Sodium

Condition Qualifier: Prophylaxis, ADULT, Veno-occlusive disease of the liver in patients undergoing hematopoietic stem cell transplantation

Condition Qualifier: Prophylaxis, PEDIATRIC, Veno-occlusive disease of the liver in patients undergoing hematopoietic stem cell transplantation

Denosumab

Giant cell tumor of bone Neoadjuvant

Dexmethylphenidate

Fatigue, cancer-related

Docetaxel

Hormone sensitive prostate cancer, Metastatic, in combination with androgen-deprivation therapy

Non-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin

Doxorubicin hydrochloride liposome

Mycosis fungoides, advanced or refractory, after failure of previous treatments

Malignant tumor of ovary, first-line therapy, in combination therapy

Dutasteride

Prostate cancer prophylaxis in high risk men

Edoxaban

Thromboembolism of vein, Following parenteral therapy; Malignant neoplastic disease

Eltrombopag Olamine

Thrombocytopenic disorder, Monotherapy, Myelodysplastic syndrome (clinical)

Enasidenib

Acute myeloid leukemia, disease Newly diagnosed, IDH2 mutation positive, monotherapy or in combination with azacitidine; in patients ineligible for intensive chemotherapy

Enoxaparin Sodium

Treatment of venous thromboembolism in patients with cancer

Eribulin Mesylate

Metastatic breast cancer; HER2-negative, first- or second-line chemotherapy for metastatic disease

Everolimus

Malignant tumor of breast, advanced, hormone receptor-negative, HER2 positive, in trastuzumab-containing regimens

Hodgkin’s disease (clinical), Relapsed or refractory, in patients who had failed or were ineligible for autologous hematopoietic stem cell transplant or after failure of a gemcitabine-, vinorelbine-, or vinblastine containing regimen

Waldenstrom macroglobulinemia, relapsed or refractory

Exemestane

Breast cancer, Neoadjuvant therapy for hormone receptor-positive disease in postmenopausal women

Breast cancer, adjuvant, premenopausal, in combination with ovarian suppression

Prevention of invasive breast cancer in postmenopausal women at increased risk

Fam-Trastuzumab Deruxtecan-nxki

Non-small cell lung cancer; Advanced disease, previously treated, HER2 mutation-positive

Febuxostat

Increased uric acid level in patients receiving chemotherapy and at intermediate to high risk of tumor lysis syndrome, Prophylaxis

Fluorouracil

Bladder cancer, in combination with cisplatin and radiotherapy

Fosaprepitant Dimeglumine

Prophylaxis, chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy; prophylaxis, radiation-induced nausea and vomiting

Fulvestrant

Malignant tumor of breast Locally advanced or metastatic, First-line endocrine therapy in postmenopausal women with hormone receptor-positive disease

Gefitinib

Head and neck cancer, Squamous cell, recurrent or metastatic, as single-agent therapy

Gemcitabine hydrochloride

Malignant tumor of nasopharynx; Recurrent or metastatic, first-line therapy in combination with cisplatin

Malignant tumor of nasopharynx; Locoregionally advanced disease, as induction therapy before chemoradiation

Non-small cell lung cancer; Stage IIIB/IV, continuation maintenance therapy as a single agent following first-line induction therapy with cisplatin and gemcitabine

Mantle cell lymphoma, relapsed or refractory, as combination therapy

Ovarian cancer, Advanced, first-line therapy in combination with paclitaxel and carboplatin

Peripheral t-cell lymphoma

Gilteritinib

Acute myeloid leukemia, disease; Newly diagnosed, with FLT3 mutation, in patients ineligible for intensive chemotherapy

Goserelin acetate

Post-chemotherapy ovarian failure prophylaxis, in patients with breast cancer receiving adjuvant anthracycline and cyclophosphamide-based therapy

Hydroxyurea

Intracranial meningioma, recurrent after surgery and radiotherapy

Ibrutinib

Hairy cell leukemia (clinical); Relapsed/Refractory, monotherapy

Diffuse non-Hodgkin's lymphoma, large cell (clinical)

Mantle cell lymphoma; In previously untreated patients, ineligible for transplant, in combination with rituximab +/- bendamustine

Imatinib mesylate

Acute lymphoblastic leukemia, Philadelphia chromosome positive, newly diagnosed, as part of combination therapy [pediatric]

Diffuse cutaneous systemic sclerosis

Imiquimod

Vulval intraepithelial neoplasia (VIN); High-grade, squamous

Inotuzumab ozogamicin

Pre B-cell acute lymphoblastic leukemia; Relapsed or refractory (PEDIATRIC)

Irinotecan Hydrochloride

Malignant tumor of pancreas; Locally advanced or metastatic, second-line in combination with a fluoropyrimidine

Iron Dextran

Prophylaxis, chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy; prophylaxis, radiation-induced nausea and vomiting

Isatuximab-irfc

Multiple myeloma; Newly diagnosed, transplant-eligible, in combination with lenalidomide, bortezomib, and dexamethasone

Isotretinoin

Neuroblastoma, high-risk, newly diagnosed, as post-consolidation therapy

Ixazomib

Multiple myeloma; Newly diagnosed, maintenance therapy

Waldenström macroglobulinemia; In combination with rituximab and dexamethasone

AL amyloidosis; Relapsed or refractory, combination therapy

Ketamine hydrochloride

Cancer pain, Opioid therapy; Adjunct

Lenalidomide

Chronic lymphoid leukemia, disease; Maintenance, after chemotherapy

AL amyloidosis; Relapsed or refractory, combination therapy

Myelodysplastic syndrome, transfusion-dependent anemia in patients at low –r intermediate-1 risk without deletion 5q abnormality

Non-Hodgkin lymphoma, in combination with rituximab

Lenvatinib

Malignant neoplasm of endometrium of corpus uteri; Advanced disease, dMMR, in combination with pembrolizumab in patients with disease progression following prior chemotherapy

Melphalan Hydrochloride

Retinoblastoma [Pediatrics]

Methylphenidate Hydrochloride

Fatigue, cancer-related

Mirtazapine

Chemotherapy-induced nausea and vomiting (Prophylaxis); Highly emetogenic chemotherapy

Malignant cachexia

Modafinil

Cancer-related fatigue

Naldemedine

Opioid-induced constipation in patients with cancer

Nelarabine

(PEDIATRIC) T-cell acute lymphoblastic leukemia; Newly diagnosed, intermediate- or high-risk disease, post-induction therapy in combination with the augmented Berlin-Frankfurt-Muenster (ABFM) regimen

Nilotinib Hydrochloride

Philadelphia chromosome-positive acute lymphoblastic leukemia; Newly diagnosed, in combination with chemotherapy

Gastrointestinal stromal tumors, advanced, resistant to or intolerant of imatinib and sunitinib

Nintedanib

Non-small cell lung cancer, Stage IIIB or IV disease, as second-line therapy in combination

Niraparib

Malignant tumor of ovary, Fallopian tube, or primary peritoneal cancer, recurrent, platinum-sensitive disease, in combination with bevacizumab

Nivolumab

Non-small cell lung cancer, metastatic or recurrent, PD-L1 expression, first-line treatment, with no EGFR or ALK tumor aberrations

Malignant melanoma, adjuvant, following complete resection of Stage IIIB, IIIC, or IV (resected distant metastases) disease

Malignant mesothelioma of pleura; Progressive or recurrent disease following platinum-based chemotherapy

Renal cell carcinoma Adjuvant treatment, in patients at moderate or high risk of recurrence following nephrectomy; in combination with ipilimumab

Liver cell carcinoma, Advanced

Merkel cell carcinoma

Malignant tumor of cervix; Recurrent, persistent, or metastatic

Malignant tumor of anus; Advanced or metastatic squamous cell disease, previously treated

Ofatumumab

Waldenström macroglobulinemia

Olanzapine

Chemotherapy-induced nausea and vomiting, moderately and/or highly emetogenic chemotherapy; Prophylaxis

Malignant cachexia

Olaparib

Malignant tumor of ovary, recurrent, platinum-sensitive, with at least 2 prior platinum-based chemotherapy regimens, as maintenance therapy

Metastatic breast cancer, HER2-negative, germline BRCA mutation-positive

Metastatic prostate cancer; Castration-resistant, previously treated with chemotherapy

Malignant tumor of pancreas; Metastatic, deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation, as maintenance therapy in patients who did not progress during first-line platinum-based chemotherapy

Malignant tumor of breast; Early, HER2-negative, germline BRCA mutation-positive, high-risk, after (neo)adjuvant chemotherapy and local treatment (radiation) therapy

Oxaliplatin

Mantle cell lymphoma; As combination therapy

Advanced or metastatic biliary tract cancer, in combination with gemcitabine

Metastatic pancreatic adenocarcinoma, first-line treatment, in combination with 5-fluorouracil, leucovorin, and irinotecan

Advanced or metastatic biliary tract cancer, in combination with gemcitabine

Paclitaxel Protein-Bound

Malignant tumor of stomach, Refractory to first line fluoropyrimidine-containing chemotherapy

Malignant tumor of breast; Neoadjuvant, in sequential combination with an anthracycline and cyclophosphamide

Malignant tumor of ovary, recurrent, platinum-resistant

Palbociclib

Malignant tumor of breast; Early, HER2-negative, hormone receptor-positive, in combination with adjuvant endocrine therapy

Malignant tumor of breast; Metastatic, HER2-negative, hormone receptor-positive, in combination with fulvestrant as initial endocrine-based therapy

Panitumumab

Squamous cell carcinoma of head and neck

Metastatic colorectal cancer, wild-type KRAS mutation, first-line therapy, in combination with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4 regimen)

Metastatic colorectal cancer, wild-type KRAS mutation, second-line therapy following fluoropyrimidine-containing chemotherapy, in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI regimen)

Panobinostat

Multiple myeloma; Relapsed/refractory, in combination with carfilzomib

Pasireotide

Carcinoid syndrome inadequately controlled with first generation somatostatin analogs, in patients with metastatic neuroendocrine tumors of the digestive tract

Pazopanib Hydrochloride

Gastrointestinal stromal tumor, metastatic or advanced, after failure of imatinib and sunitinib

Malignant tumor of ovary, Fallopian tube or primary peritoneal cancer, advanced, previously treated, in combination with paclitaxel

Malignant tumor of thyroid gland Differentiated, locally advanced or metastatic, progressive, refractory to radioactive iodine

Renal cell carcinoma, Adjuvant therapy following nephrectomy in patients at high risk for recurrence

Pegaspargase

Extranodal NK/T-cell lymphoma, nasal type

Pegfilgrastim

Harvesting of peripheral blood stem cells, prior to autologous stem-cell transplantation

Peginterferon alfa-2a

Polycythemia vera

Essential thrombocythemia

Peginterferon alfa-2b

Essential thrombocythemia

Pembrolizumab

Malignant mesothelioma of pleura; Previously treated

Malignant mesothelioma of pleura Previously untreated, advanced, in combination with a platinum agent and pemetrexed

Triple-negative breast cancer; Early, neoadjuvant, in combination with standard chemotherapy

Renal cell carcinoma; First-line, in combination with lenvatinib

Malignant tumor of anus; Advanced or metastatic squamous cell disease, previously treated

Biliary Tract Cancer

Pemetrexed

Nonsquamous nonsmall cell neoplasm of lung; Stage IIIB/IV or recurrent, continuation maintenance therapy in combination with bevacizumab following platinum-based, first-line therapy

Ovarian cancer, recurrent

Pertuzumab

Malignant tumor of breast, adjuvant, HER2 overexpression, in combination with trastuzumab and chemotherapy

Malignant tumor of stomach or Gastroesophageal junction cancer; Metastatic, HER2-positive, in combination with trastuzumab and chemotherapy

Polatuzumab Vedotin-piiq

Diffuse non-Hodgkin's lymphoma, large cell (clinical); Intermediate- or high-risk, previously untreated, in combination with cyclophosphamide, DOXOrubicin, predniSONE, and rituximab

Pomalidomide

AL amyloidosis; Relapsed or refractory, combination therapy with dexamethasone

Multiple myeloma; Relapsed or refractory, in combination with a steroid in a triplet regimen

Ponatinib Hydrochloride

Philadelphia chromosome-positive acute lymphoblastic leukemia; Newly diagnosed, in combination with chemotherapy

Porfimer sodium

Cholangiocarcinoma of the biliary tract, unresectable, after double stenting

Prochlorperazine

Radiotherapy-induced nausea and vomiting, Prophylaxis

Pyridoxine

Prophylaxis, acral erythema due to cytotoxic therapy in patients receiving capecitabine-containing chemotherapy

Ramucirumab

Metastatic urothelial carcinoma; Or advanced, with progression after platinum-containing chemotherapy

Metastatic Breast Cancer, HER2-Negative. First-line, in combination with Docetaxel

Regorafenib

Osteosarcoma of bone; Metastatic or advanced, progressive, previously treated

Risedronate Sodium

Prophylaxis Osteopenia, Secondary to androgen-deprivation therapy in patients with prostate cancer

Rituximab

Burkitt’s lymphoma (clinical) in combination with chemotherapy

Mantle cell lymphoma untreated, maintenance therapy

Chronic lymphoid leukemia, disease maintenance, following rituximab-containing chemotherapy

Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia; CD20-positive, in combination with chemotherapy

Immune thrombocytopenia; In combination with a corticosteroid

Immune thrombocytopenia, previously treated [pediatric]

Mantle cell lymphoma, untreated, induction therapy, in combination with anthracycline-based regimens

Post-transplant lymphoproliferative disorder [pediatric patients]

Thrombotic thrombocytopenic purpura, in combination with plasma exchange

Rivaroxaban

Thromboembolism of vein; Malignant neoplastic disease

Thromboembolism of vein, Prophylaxis; In high-risk outpatients, Malignant neoplastic disease

Romiplostim

Thrombocytopenic disorder and Myelodysplastic syndrome

Chronic idiopathic thrombocytopenic purpura [pediatric]

Ruxolitinib Phosphate

Graft versus host disease following allogeneic stem cell transplantation, steroid-refractory

Selinexor

Malignant neoplasm of endometrium of corpus uteri Metastatic or recurrent, as maintenance therapy

Sodium Ferric Gluconate Complex

Prophylaxis, chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy; prophylaxis, radiation-induced nausea and vomiting

Sorafenib Tosylate

Gastrointestinal stromal tumor Advanced or metastatic disease, after failing treatment with imatinib and sunitinib

Malignant tumor of ovary; Primary peritoneal cancer, maintenance therapy

Renal cell carcinoma, Adjuvant therapy following nephrectomy in patients at high risk for recurrence

Acute myeloid leukemia, disease; FLT3-ITD mutation-positive, maintenance therapy following allogeneic HSCT

Melanoma, unresectable or metastatic, in combination

Non-small cell lung cancer, Advanced

Sotorasib

Pancreatic cancer, Locally advanced or metastatic, KRAS G12C-mutated, in patients who have received at least 1 prior systemic therapy

Sunitinib malate

Malignant tumor of thyroid gland Locally advanced or metastatic, progressive, refractory to radioactive iodine

Renal cell carcinoma, high-risk, adjuvant therapy

Metastatic breast cancer, HER2-negative

Non-small cell lung cancer, advanced or metastatic, in combination therapy, in previously treated patients

Pheochromocytoma Metastatic, progressive

Paraganglioma Metastatic, progressive

Tamoxifen

Malignant tumor of breast, adjuvant therapy, premenopausal, hormone receptor-positive, in combination with ovarian suppression

Temozolomide

(Adult) Medulloblastoma; Relapsed or recurrent

(Pediatric) Medulloblastoma; Relapsed or recurrent

Neuroendocrine tumor of pancreas Advanced, progressive disease, as monotherapy or in combination with capecitabine

Temsirolimus

Malignant neoplasm of endometrium of corpus uteri; Advanced or recurrent

Thalidomide

Non-small cell lung cancer, advanced or metastatic, in combination with a platinum-based regimen

Systemic mast cell disease

Toremifene citrate

Prophylaxis of vertebral fracture, Secondary to androgen deprivation therapy in patients with prostate cancer

Toripalimab-tpzi

Non-small cell lung cancer Neoadjuvant therapy in combination with platinum-containing doublet chemotherapy, followed by one adjuvant cycle with combination therapy, then continued as single-agent maintenance therapy

Non-small cell lung cancer Advanced disease, first-line therapy in combination with platinum-containing doublet chemotherapy followed by toripalimab maintenance therapy (with pemetrexed for nonsquamous cell disease)

Trabectedin

Malignant tumor of ovary; In combination with pegylated liposomal DOXOrubicin, following 1 or 2 previous platinum-based chemotherapy regimens

Trametinib Dimethyl Sulfoxide

Malignant tumor of ovary; Or peritoneal cancer, low-grade serous carcinoma, recurrent, as monotherapy

Trastuzumab

Metastatic breast cancer HER2 overexpression, hormone receptor positive, postmenopausal women, in combination with anastrozole

Trifluridine/Tipiracil

Malignant neoplasm of colon and/or rectum Metastatic, first-line treatment in combination with bevacizumab; in patients not eligible for intensive chemotherapy

Triptorelin pamoate

Post-chemotherapy ovarian failure, in premenopausal women with breast cancer, prophylaxis

Vandetanib

Malignant tumor of ovary, recurrent, platinum-resistant

Non-small cell lung cancer, locally advanced or metastatic, after failure of first- or second-line chemotherapy

Vedolizumab

Acute graft-versus-host disease - Steroid-refractory

Vemurafenib

Malignant melanoma; Adjuvant therapy, cutaneous, with BRAF-V600 mutation

Hairy cell leukemia (clinical); Relapsed/Refractory, in combination with rituximab

Hairy cell leukemia (clinical); Relapsed/Refractory, monotherapy

Venetoclax

Multiple myeloma; Relapsed or refractory, t(11;14) positive, combination therapy

Myelodysplastic syndrome (clinical); In combination with azacitidine or decitabine

Vinorelbine Tartrate

Malignant mesothelioma of pleura

Malignant pleural mesothelioma

Zanubrutinib

Chronic lymphoid leukemia, disease; or Malignant lymphoma - small lymphocytic

Zoledronic acid

Breast cancer, early stage, adjuvant

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