The European Medicines Agency review of entrectinib for the treatment of adult or paediatric patients with solid tumours who have a neurotrophic tyrosine receptor kinase gene fusio...

por Delgado, J., Pean, E., Melchiorri, D., Migali, C., Josephson, F., Enzmann, H., Pignatti, F.
Publicado 2021

The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer

por Delgado, J., Vleminckx, C., Sarac, S., Sosa, A., Bergh, J., Giuliani, R., Enzmann, H., Pignatti, F.
Publicado 2021

The EMA assessment of encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal carcinoma harbouring the BRAFV600E mutation who have...

por Trullas, A., Delgado, J., Koenig, J., Fuerstenau, U., Dedorath, J., Hausmann, S., Stock, T., Enzmann, H., Pignatti, F.
Publicado 2021

The EMA assessment of pembrolizumab as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient color...

por Trullas, A., Delgado, J., Genazzani, A., Mueller-Berghaus, J., Migali, C., Müller-Egert, S., Zander, H., Enzmann, H., Pignatti, F.
Publicado 2021

The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer

por Michaleas, S., Moreno Oliver, A., Mueller-Berghaus, J., Sarac, S.B., van der Elst, M.E., Müller-Egert, S., Zander, H., Enzmann, H., Pignatti, F.
Publicado 2022

The European Medicines Agency review of the initial application of atezolizumab and the role of PD-L1 expression as biomarker for checkpoint inhibitors

por Araujo-Fernandez, I., Delgado, J., Moscetti, L., Sarac, S.B., Zander, H., Mueller-Egert, S., Dunder, K., Pean, E., Bergmann, L., Enzmann, H., Pignatti, F.
Publicado 2020

The EMA assessment of avapritinib in the treatment of gastrointestinal stromal tumours harbouring the PDGFRA D842V mutation

por Trullas-Jimeno, A., Delgado, J., Garcia-Ochoa, B., Wang, I., Sancho-Lopez, A., Payares-Herrera, C., Dalhus, M.L., Strøm, B.O., Egeland, E.J., Enzmann, H., Pignatti, F.
Publicado 2021

“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?

por Eichler, H‐G, Bloechl‐Daum, B, Bauer, P, Bretz, F, Brown, J, Hampson, LV, Honig, P, Krams, M, Leufkens, H, Lim, R, Lumpkin, MM, Murphy, MJ, Pignatti, F, Posch, M, Schneeweiss, S, Trusheim, M, Koenig, F
Publicado 2016

Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines

por Zarkavelis, G., Amylidi, A.L., Verbaanderd, C., Cherny, N.I., Metaxas, Y., de Vries, E.G.E., Zygoura, P., Amaral, T., Jordan, K., Strijbos, M., Dafni, U., Latino, N., Galotti, M., Lordick, F., Giuliani, R., Pignatti, F., Pentheroudakis, G.
Publicado 2022

From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients

por Eichler, H‐G, Baird, LG, Barker, R, Bloechl‐Daum, B, Børlum‐Kristensen, F, Brown, J, Chua, R, Del Signore, S, Dugan, U, Ferguson, J, Garner, S, Goettsch, W, Haigh, J, Honig, P, Hoos, A, Huckle, P, Kondo, T, Le Cam, Y, Leufkens, H, Lim, R, Longson, C, Lumpkin, M, Maraganore, J, O'Rourke, B, Oye, K, Pezalla, E, Pignatti, F, Raine, J, Rasi, G, Salmonson, T, Samaha, D, Schneeweiss, S, Siviero, PD, Skinner, M, Teagarden, JR, Tominaga, T, Trusheim, MR, Tunis, S, Unger, TF, Vamvakas, S, Hirsch, G
Publicado 2015