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                                      • Horizon Scanning in Oncology - Reports and Fact Sheets

                                      Horizon Scanning in Oncology - Reports and Fact Sheets

                                      Bild1-long22

                                      Decision Support Documents

                                      Within the scope of the Horizon Scanning in Oncology project, the LBI-HTA periodically published assessments until 2019 on novel cancer drugs with a likely therapeutical and/or financial outcome. These assessments served as decision aids for funding agencies and the decision-making network "HTA in hospitals " alike.

                                      Since January 2020, monthly Fact Sheets will be conducted concerning all pharmaceutical oncological therapies that have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

                                      Oncology Fact Sheets since January 2020:

                                      Fact Sheet No. 40 (January 2021) New!
                                      Pemigatinib (Pemazyre®) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement

                                      Fact Sheet No. 39 (January 2021) New!
                                      Selinexor (Nexpovio®) in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM)

                                      Fact Sheet No. 38 (January 2021) New!
                                      Pembrolizumab (Keytruda®) is indicated for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin lymphoma (cHL)

                                      Fact Sheet No. 37 (Dezember 2020)
                                      Tucatinib (Tukysa®) with trastuzumab and capecitabine for the treatment of HER2-positive locally advanced or metastatic breast cancer

                                      Fact Sheet No. 36 (Dezember 2020)
                                      Selpercatinib (Retsevmo®) for the treatment of RET-fusion positive NSCLC, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer

                                      Fact Sheet No. 35 (Dezember 2020)
                                      Moxetumomab pasudotox (Lumoxiti®) for the treatment of patients with relapsed or refractory hairy cell leukaemia (HCL)

                                      Fact Sheet No. 34 (Dezember 2020)
                                      Pembrolizumab (Keytruda®) as monotherapy for the first-line treatment of MSI H or dMMR colorectal cancer

                                      Fact Sheet Nr. 33 (Dezember 2020)
                                      Fedratinib (Inrebic®) for the treatment of primary and secondary myelofibrosis

                                      Fact Sheet No. 32 (Dezember 2020)
                                      Trastuzumab deruxtecan (Enhertu®) in patients with previously treated HER2-positive breast cancer

                                      Fact Sheet No. 31 (Dezember 2020) Update
                                      Avelumab (Bavencio®) as monotherapy for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma

                                      Fact Sheet No. 30 (November 2020) Update
                                      A fixed-dose combination of pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) for the treatment of early and metastatic breast cancer

                                      Fact Sheet No. 29 (November 2020) Update
                                      Carfilzomib (Kyprolis®) with daratumumab and dexamethasone for the treatment of adult patients with multiple myeloma (MM)

                                      Fact Sheet No. 28 (November 2020) Update
                                      Tagraxofusp (Elzonris®) in blastic plasmacytoid dendritic-cell neoplasm (BPDCN)

                                      Fact Sheet No. 27 (October 2020) Update
                                      Autologous anti-CD19-transduced CD3+ cells (Tecartus®) for the treatment of relapsed or refractory mantle cell lymphoma (MCL)

                                      Fact Sheet No. 26 (October 2020) Update
                                      Nivolumab (Opdivo®) as monotherapy for the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OESCC)

                                      Fact Sheet No. 25 (October 2020) Update
                                      Blinatumomab (Blincyto®) for the treatment of patients with Philadelphia chromosome positive B-precursor acute lymphoblastic leukaemia (ALL)

                                      Fact Sheet No. 24 (September 2020) Update
                                      Olaparib (Lynparza®) plus bevacizumab as first-line maintenance treatment in patients with ovarian cancer

                                      Fact Sheet No. 23 (September 2020) Update
                                      Olaparib (Lynparza®) for metastatic castration-resistant prostate cancer (mCRPC)  

                                      Fact Sheet No. 22 (September 2020) Update
                                      Niraparib (Zejula®) in patients with newly diagnosed advanced ovarian cancer

                                      Fact Sheet No. 21 (September 2020) Update
                                      Nivolumab (Opdivo®) plus ipilimumab (Yervoy®) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC)

                                      Fact Sheet No. 20 (September 2020) Update
                                      Atezolizumab (Tecentriq®) plus bevacizumab for the treatment of advanced or unresectable hepatocellular carcinoma (HCC)

                                      Fact Sheet No. 19 (Juli 2020) Update
                                      Ibrutinib (Imbruvica®) as a single agent or in combination with rituximab or obinutuzumab  for the treatment of previously untreated chronic lymphocytic leukaemia (CLL)

                                      Fact Sheet No. 18 (Juli 2020) Update
                                      Durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC)

                                      Fact Sheet No. 17 (Juli 2020) Update
                                      Belantamab mafodotin (Blenrep®) as monotherapy for the treatment of relapsed or refractory multiple myeloma (MM)

                                      Fact Sheet No. 16 (Juli 2020) Update
                                      Avapritinib (Ayvakyt®) for the treatment of gastrointestinal stromal tumours (GIST)

                                      Fact Sheet No. 15 (Juli 2020) Update
                                      Acalabrutinib (Calquence®) for the treatment of chronic lymphocytic leukaemia (CLL)

                                      Fact Sheet No. 14 (ad April 2020)
                                      Carmustine (Carmustine Obvius®) as conditioning treatment before transplantation in patients with Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphomas (NHL) 

                                      Fact Sheet No. 13 (Mai 2020) Update
                                      Entrectinib (Rozlytrek®) for the treatment of patients whose solid tumours have a NTRK gene fusion, or patients with ROS1-positive advanced NSCLC

                                      Fact Sheet No. 12 (Mai 2020) Update 
                                      Alpelisib (Piqray®) plus fulvestrant for PIK3CA-mutated, hormone receptor–positive advanced breast cancer

                                      Fact Sheet No. 11 (Mai 2020) 
                                      Maintenance olaparib (Lynparza®) for the treatment of patients with germline BRCA-mutated metastatic pancreatic cancer

                                      Fact Sheet No. 10 (April 2020)
                                      Glasdegib (Daurismo®) with low-dose cytarabine (LDAC) in patients with newly diagnosed acute myeloid leukaemia (AML)

                                      Fact Sheet No. 9 (April 2020) 
                                      Daratumumab (Darzalex®) in a new pharmaceutical form associated with a new strength and a new route of administration for the treatment of multiple myeloma

                                      Fact Sheet No. 8 (April 2020) Update
                                      Cabazitaxel Accord for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel containing regimen

                                      Fact Sheet No. 7 (April 2020) 
                                      Encorafenib (Braftovi®) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation

                                      Fact Sheet No. 6 (March 2020) 
                                      Isatuximab (Sarclisa®) plus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (MM)

                                      Fact Sheet No. 5 (March 2020) 
                                      Brentuximab vedotin (Adcetris®) with chemotherapy for CD30-positive peripheral T-cell lymphoma (PTCL)

                                      Fact Sheet No. 4 (February 2020) 
                                      Brigatinib (Alunbrig®) in ALK-positive non–small-cell lung cancer (NSCLC)

                                      Fact Sheet No. 3 (January 2020)
                                      Rituximab (MabThera®) for the treatment of paediatric patients with previously untreated advanced stage CD20 positive DLBCL, BL, BAL, or BLL

                                      Fact Sheet No. 2 (January 2020) 
                                      Darolutamide (Nubeqa®) in nonmetastatic, castration-resistant prostate cancer (nmCRPC)

                                      Fact Sheet No. 1 (January 2020) 
                                      Venetoclax (Venclyxto®) and obinutuzumab in patients with chronic lymphocytic leukaemia (CLL) and coexisting conditions

                                       

                                      Publikation series October 2009 - December 2020 (in English):

                                      DSD HSO No 91
                                      Pembrolizumab (Keytruda®) as first-line therapy for PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (NSCLC)

                                      DSD HSO No. 90
                                      Enzalutamide (Xtandi®) in addition to standard first-line therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC)

                                      DSD HSO No. 89
                                      Brentuximab vedotin (Adcetris®) in combination with chemotherapy for CD30-positive peripheral T-cell lymphoma (PTCLs)

                                      DSD HSO No. 88
                                      Darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC)

                                      DSD HSO No. 87
                                      Atezolizumab (Tecentriq®) with nab-paclitaxel (Abraxane®) for the treatment of advanced triple-negative breast cancer (aTNBC)

                                      DSD HSO No. 86
                                      Olaparib (Lynparza®) as first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer'

                                      DSD HSO No. 85
                                      Ibrutinib (Imbruvica®) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia

                                      DSD HSO No. 84
                                      Enzalutamide (Xtandi®) in patients with nonmetastatic, castration-resistant prostate cancer (CRPC)

                                      DSD HSO No. 83
                                      Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of metastatic non-small-cell lung cancer (NSCLC)

                                      DSD HSO No. 82
                                      Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) for the first-line treatment of patients with advanced RCC

                                      DSD HSO No. 81
                                      Daratumumab (Darzalex®) in combination with bortezomib, melphalan and prednisone for untreated myeloma

                                      DSD HSO No. 80
                                      Osimertinib (Tagrisso®) for the initial treatment of EGFR-mutated advanced non–small-cell lung cancer (NSCLC)

                                      DSD HSO No. 79
                                      Rituximab (MabThera®) after autologous stem-cell transplantation (ASCT) in mantle cell lymphoma (MCL)

                                      DSD HSO No. 78
                                      Abemaciclib (Verzenio®) in combination with a nonsteroidal aromatase inhibitor (NSAI) as initial therapy for advanced breast cancer (ABC)

                                      DSD HSO No. 77
                                      Alectinib as monotherapy for the first-line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC)

                                      DSD HSO No. 76
                                      Durvalumab (Imfinzi™) for the treatment of patients with stage III non-small-cell lung cancer after prior chemoradiotherapy

                                      DSD HSO No. 75
                                      Nivolumab (Opdivo®) for metastatic DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)

                                      DSD HSO No. 74
                                      Midostaurin with standard chemotherapy in FLT3-Positive Acute Myeloid Leukaemia 

                                      DSD HSO No. 73
                                      Regorafenib indicated  as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib  

                                      DSD HSO No. 72
                                      Abemaciclib (Verzenio®) in combination with fulvestrant for treatment of HR-positive, HER2-negative advanced breast cancer (ABC) 

                                      DSD HSO No. 71
                                      Olaparib (Lynparza®) in patients with BRCA-mutated metastatic breast cancer 

                                      DSD HSO No. 70
                                      Pembrolizumab (Keytruda®) as second-line treatment for patients with advanced urothelial carcinoma (UC)

                                      DSD HSO No. 69
                                      Ceritinib (Zykadia®) as first-line therapy for patients with advanced ALK-positive non-small cell lung cancer

                                      DSD HSO No. 68
                                      Atezolizumab (Tecentriq®) in previously treated non-small cell lung cancer (NSCLC)

                                      DSD HSO No. 67
                                      Ipilimumab (Yervoy®) in the adjuvant therapy for high-risk stage III cutaneous melanoma

                                      DSD HSO No. 66
                                      Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy

                                      DSD HSO No. 65
                                      Ribociclib in combination with letrozole for the first-line therapy of HR-positive, HER2-negative recurrent or metastatic breast cancer

                                      DSD HSO No. 64
                                      Palbociclib (Ibrance®) in combination with fulvestrant for the treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer

                                      DSD HSO No. 63
                                      Ixazomib (Ninlaro®) in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma (MM)

                                      DSD HSO No. 62
                                      Venetoclax (VenclextaTM) for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) with chromosome 17p deletion

                                      DSD HSO No. 61
                                      Atezolizumab (TecentriqTM) for the treatment of locally advanced and metastatic urothelial carcinoma 

                                      DSD HSO No. 60
                                      Obinutuzumab (Gazyvaro®) in combination with bendamustine for the treatment of relapsed/refractory follicular lymphoma (FL)

                                      DSD HSO No. 59
                                      Afatinib (Giotrif®) in patients with non-small cell lung cancer (NSCLC) who are refractory to erlotinib/gefitinib and afatinib monotherapy

                                      DSD HSO No. 58
                                      Pembrolizumab (Keytruda®) in previously treated advanced non-small cell lung cancer (NSCLC)

                                      DSD HSO No. 57
                                      Ofatumumab (Arzerra®) as maintenance therapy in patients with relapsed chronic lymphocytic leukaemia (CLL)

                                      DSD HSO No. 56
                                      Bevacizumab (Avastin®) in addition to standard chemotherapy for the first-line treatment of ovarian cancer

                                      DSD HSO No. 55
                                      Pembrolizumab (Keytruda®) for the treatment of advanced melanoma

                                      DSD HSO No. 54
                                      Ramucirumab in combination with paclitaxel as second-line treatment for adult patients with advanced gastric or gastro-oesophageal junction carcinoma

                                      DSD HSO No. 53
                                      Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer

                                      DSD HSO No. 52
                                      Carfilzomib (Kyprolis®) for patients with relapsed multiple myeloma who have received one to three prior lines of therapy

                                      DSD HSO No. 51
                                      Bevacizumab (Avastin®) in combination with chemotherapy as second-line therapy for HER2-negative, locally recurrent or metastatic breast cancer that has progressed after first-line treatment with bevacizumab plus chemotherapy

                                      DSD HSO No. 50
                                      Nivolumab (Opdivo®) as single-agent first-line therapy for unresectable or metastatic melanoma

                                      DSD HSO No. 49
                                      Idelalisib (Zydelig®) in addition to rituximab for the treatment of relapsed chronic lymphocytic leukaemia

                                      DSD HSO No. 48
                                      Bevacizumab (Avastin®) for platinum-resistant recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer

                                      DSD HSO No. 47
                                      Ibrutinib (Imbruvica®) for relapsed or refractory chronic lymphocytic leukaemia

                                      DSD HSO No. 46
                                      Bevacizumab (Avastin®) as maintenance therapy after first progression on bevacizumab for patients with advanced colorectal carcinoma

                                      DSD HSO No. 45
                                      Obinutuzumab (Gazyva®) for previously untreated patients with chronic lymphocytic leukaemia (CLL)

                                      DSD HSO No. 44
                                      Radium-223 dichloride (Xofigo®) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

                                      DSD HSO No. 43
                                      Nab-Paclitaxel (Abraxane®) as first-line therapy for metastatic adenocarcinoma of the pancreas

                                      DSD HSO No. 42
                                      Dabrafenib (Tafinlar®) in previously untreated subjects with BRAF mutation-positive advanced (stage III) or metastatic (stage IV) melanoma

                                      DSD HSO No. 41
                                      Afatinib (Giotrif®) for the treatment of EGFR TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s)

                                      DSD HSO No. 40
                                      Regorafenib (Stivarga®) for heavily pretreated patients with metastatic colorectal cancer (mCRC)

                                      DSD HSO No. 39
                                      Pomalidomide (Pomalyst®) for the ? 3rd-line therapy of patients with relapsed and refractory multiple myeloma

                                      DSD HSO No. 38
                                      Aflibercept (Zaltrap®) in addition to FOLFIRI for the 2nd line therapy of metastatic colorectal cancer

                                      DSD HSO No. 37
                                      Enzalutamide (Xtandi®) for patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy

                                      DSD HSO No. 36
                                      Trastuzumab emtansine (KadcylaTM) for previously treated patients with
                                      HER2-positive advanced/ metastatic breast cancer

                                      DSD HSO No. 35
                                      Crizotinib (Xalkori®) for the treatment of anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC)

                                      DSD HSO No. 34
                                      Trametinib for advanced or metastatic BRAF V600 mutation-positive melanoma

                                      DSD HSO No. 33
                                      Lenalidomide (Revlimid®) for the first-line therapy of transplant-ineligible patients with multiple myeloma

                                      DSD HSO No. 32
                                      Everolimus (Afinitor® or Votubia®) in combination with exemestane in postmenopausal women with oestrogen receptor positive, HER2-negative locally advanced or metastatic breast cancer who are refractory to letrozole or anastrozole

                                      DSD HSO No. 31
                                      Pertuzumab (Omnitarg/Perjeta®) for the first-line therapy of metastatic HER2 positive breast cancer

                                      DSD HSO No. 30
                                      Ipilimumab (Yervoy®) for the first-line therapy of advanced/metastatic cutaneous melanoma

                                      DSD HSO No. 29
                                      Bortezomib (Velcade®) as consolidation or maintenance therapy after autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma

                                      DSD HSO No. 28
                                      Lenalidomide (Revlimid®) for the treatment of low /intermediate-1 risk myelodysplastic syndrome with chromosome 5q deletion

                                      DSD HSO No. 27
                                      Bevacizumab (Avastin®) in combination with chemotherapy in previously treated metastatic breast cancer

                                      DSD HSO No. 26
                                      Brentuximab (Adcetris®) for the treatment of relapsed Hodgkin’s lymphoma (HL) or relapsed systemic anaplastic large cell lymphoma (sALCL)

                                      DSD HSO No. 25
                                      Romidepsin (Istodax®) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) after prior systemic therapy  

                                      DSD HSO No. 24
                                      Everolimus (Afinitor®) for the treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin

                                      DSD HSO No. 23
                                      Vemurafenib for patients with BRAF V600E mutation positive advanced/metastatic melanoma

                                      DSD HSO No. 22
                                      Erlotinib (Tarceva®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations

                                      DSD HSO No. 21
                                      Axitinib (AG013736, Inlyta®) for the second-line treatment of metastatic renal cell carcinoma (mRCC)

                                      DSD HSO No. 20
                                      Abiraterone acetate (ZytigaTM) as 2nd-line therapy for the treatment of metastatic castration-resistant prostate cancer after docetaxel therapy

                                      DSD HSO No. 19
                                      S-1 (TeysunoTM) as first-line therapy for patients with advanced non-small cell lung cancer

                                      DSD HSO No. 18
                                      Eribulin (Halaven®) as third- or late- line mono-therapy for advanced/metastatic breast cancer

                                      DSD HSO No. 17
                                      Dasatinib (Sprycel®) for the 1st-line treatment of Philadelphia-chromosome positive chronic myeloid leukemia in the chronic phase

                                      DSD HSO No. 16
                                      Second-line chemotherapy with cabazitaxel (Jevtana®) for the treatment of castration-resistant metastatic prostate cancer

                                      DSD HSO No. 15
                                      Nilotinib (Tasigna®) for the 1st-line treatment of Philadelphia chromosome positive chronic myeloid leukemia in the chronic phase

                                      DSD HSO No. 14
                                      Ipilimumab for pre-treated patients with advanced/metastatic melanoma

                                      DSD HSO No. 13
                                      Pazopanib (Votrient®) for the treatment of locally advanced and/or metastatic renal cell carcinoma

                                      DSD HSO No. 12
                                      Trastuzumab (Herceptin®) in addition to standard chemotherapy as first-line therapy for advanced gastric cancer

                                      DSD HSO No. 11
                                      Panitumumab (Vectibix®) for the first-line treatment of metastatic colorectal cancer

                                      DSD HSO No. 11/ 1st update 2011
                                      Panitumumab (Vectibix®) as 1st-line combination therapy for the treatment of WT KRAS metastatic colorectal cancer

                                      DSD HSO No. 10
                                      Bendamustine (Ribomustin®/Treanda®/ Levact®) for indolent non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and multiple myeloma

                                      DSD HSO No. 9
                                      Lapatinib ditosylate (Tyverb/Tykerb®) as first-line therapy for the treatment of advanced/metastatic breast cancer

                                      DSD HSO No. 8
                                      Plerixafor (Mozobil®) for autologous stem cell transplantation in patients with lymphoma and multiple myeloma

                                      DSD HSO No. 7
                                      Trabectedin (Yondelis®) for second-line recurrent platinum-sensitive ovarian cancer

                                      DSD HSO No. 6
                                      Gefitinib (Iressa®) for the first-line treatment of non-small cell lung cancer

                                      DSD HSO No. 6/ 1st update 2011
                                      Gefitinib (Iressa®) for the 1st-line treatment of non-small cell lung cancer – 1st Update 2011

                                      DSD HSO No. 5
                                      Ibritumomab tiuxetan (Zevalin®) as consolidation therapy after first remission in patients with follicular lymphoma

                                      DSD HSO No. 4
                                      Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia

                                      DSD HSO No.4/ 1st update 2011
                                      Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia – 1st Update 2011

                                      DSD HSO No. 3
                                      Everolimus (Afinitor®) for the treatment of advanced/metastatic kidney cancer

                                      DSD HSO No. 2
                                      Cetuximab (Erbitux®) in EGFR-expressing Non-Small Cell Lung Cancer

                                      DSD HSO No. 1
                                      Azacitidine (Vidaza®) for the treatment of myelodysplastic syndromes

                                      Contact: Nicole Grössmann

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