Sinan B. Sarac

Copenhagen, Denmark

Last Updated: 09/26/2026

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Found 20 publications

Common pitfalls in oncology drug applications aiming for conditional marketing authorization.

Common pitfalls in oncology drug applications aiming for conditional marketing authorization.

Journal: British journal of clinical pharmacology

Published: July 25, 2024

Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Journal: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

Published: February 22, 2023

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

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

Journal: ESMO open

Published: March 02, 2022

Outcomes and endpoints in clinical trials supporting the marketing authorisation of treatments in paediatric acute lymphoblastic leukaemia.

Outcomes and endpoints in clinical trials supporting the marketing authorisation of treatments in paediatric acute lymphoblastic leukaemia.

Journal: Drug discovery today

Published: December 09, 2021

The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma.

The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma.

Journal: HemaSphere

Published: September 07, 2021

The changing landscape of treatment options in childhood acute lymphoblastic leukaemia.

The changing landscape of treatment options in childhood acute lymphoblastic leukaemia.

Journal: Drug discovery today

Published: July 12, 2021

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

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

Journal: ESMO open

Published: February 01, 2021

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

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

Journal: ESMO open

Published: October 09, 2020

Combination therapies in immuno-oncology: differentiated regulatory approaches

Combination therapies in immuno-oncology: differentiated regulatory approaches

Journal: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz

Published: June 03, 2020

EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma.

EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma.

Journal: The oncologist

Published: May 04, 2020

European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Journal: ESMO open

Published: July 31, 2019

Approval of new medicinal products - administrative procedures

Approval of new medicinal products - administrative procedures

Journal: Ugeskrift for laeger

Published: May 25, 2019

Showing 1-12 of 20

Last Updated: 09/26/2026