Cargando…

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma

Mostrar otras versiones (1)

On August 28, 2015, a marketing authorization valid through the European Union was issued for panobinostat, in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including b...

Descripción completa

Detalles Bibliográficos
Autores principales:	Tzogani, Kyriaki, van Hennik, Paula, Walsh, Ita, De Graeff, Pieter, Folin, Annika, Sjöberg, Jan, Salmonson, Tomas, Bergh, Jonas, Laane, Edward, Ludwig, Heinz, Gisselbrecht, Christian, Pignatti, Francesco
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	AlphaMed Press 2017
Materias:	Regulatory Issues: EMA
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947444/ https://www.ncbi.nlm.nih.gov/pubmed/29192015 http://dx.doi.org/10.1634/theoncologist.2017-0301

Ejemplares similares

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma
por: Tzogani, Kyriaki, et al.
Publicado: (2018)

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma
por: Tzogani, Kyriaki, et al.
Publicado: (2018)

The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy
por: Tzogani, Kyriaki, et al.
Publicado: (2017)

The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors
por: Tesileanu, C Mircea S, et al.
Publicado: (2023)

Beyond “Intent‐to‐treat” and “Per protocol”: Improving assessment of treatment effects in clinical trials through the specification of an estimand
por: Pétavy, Frank, et al.
Publicado: (2020)

European Medicines Agency review of midostaurin (Rydapt) for the treatment of adult patients with acute myeloid leukaemia and systemic mastocytosis
por: Tzogani, Kyriaki, et al.
Publicado: (2019)

European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
por: Tzogani, Kyriaki, et al.
Publicado: (2019)

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer
por: Stanel, Stefan Cristian, et al.
Publicado: (2017)

Drug Lag and Key Regulatory Barriers in the Emerging Markets
por: Wileman, Harriet, et al.
Publicado: (2010)

Regulations and guidelines governing stem cell based products: Clinical considerations
por: George, Bobby
Publicado: (2011)

Regulatory Considerations for Biosimilars
por: Nellore, Ranjani
Publicado: (2010)

Registration of Medical Devices
por: George, Bobby
Publicado: (2010)

Implications of ICH-E5: Assessment of drug's sensitivity to ethnic factors and necessity of a bridging study for global drug development
por: Gupta, Sandeep Kumar
Publicado: (2011)

Regulatory requirements for marketing fixed dose combinations
por: Jayasheel, B. G.
Publicado: (2010)

Injury and death in clinical trials and compensation: Rule 122 DAB
por: Ghooi, Ravindra. B.
Publicado: (2013)

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests
por: Li, Hongran, et al.
Publicado: (2021)

China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval
por: Lv, Yunfeng, et al.
Publicado: (2020)

Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
por: Li, Hongran, et al.
Publicado: (2021)

China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents
por: Lv, Yunfeng, et al.
Publicado: (2022)

Panobinostat and Multiple Myeloma in 2018
por: Yee, Andrew J., et al.
Publicado: (2018)

Vitamin D supplementation in older people in COVID-19 pandemic
por: Siuka, Darko, et al.
Publicado: (2021)

Long Covid and menopause - the important role of hormones in Long Covid must be considered
por: Newson, Louise, et al.
Publicado: (2021)

Commentary on the European Medicines Agency's extended mandate: Protecting public health in times of crisis and improving availability of medicines and medical devices
por: Abed, Inga, et al.
Publicado: (2022)

Efficacy of Panobinostat for the Treatment of Multiple Myeloma
por: Eleutherakis-Papaiakovou, Evangelos, et al.
Publicado: (2020)

Panobinostat for the treatment of multiple myeloma: the evidence to date
por: Bailey, Hanna, et al.
Publicado: (2015)

FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
por: Bhatnagar, Vishal, et al.
Publicado: (2017)

The Combination of Panobinostat and Melphalan for the Treatment of Patients with Multiple Myeloma
por: Gkotzamanidou, Maria, et al.
Publicado: (2022)

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
por: Pulte, Elizabeth Dianne, et al.
Publicado: (2018)

Screening of chemicals for human bioaccumulative potential with a physiologically based toxicokinetic model
por: Tonnelier, Arnaud, et al.
Publicado: (2011)

Indian Regulatory Update: Jan-May 2014
por: Suvarnapathaki, Kedar
Publicado: (2014)

Sensory irritation as a basis for setting occupational exposure limits
por: Brüning, Thomas, et al.
Publicado: (2014)

Indian Regulatory Update: June-August 2014
por: Suvarnapathaki, Kedar
Publicado: (2014)

Indian regulatory update 2013
por: Suvarnapathaki, Kedar
Publicado: (2013)

Indian Regulatory Update: September-November 2013
por: Suvarnapathaki, Kedar
Publicado: (2014)

Indian Regulatory Update: January-March 2015
por: Suvarnapathaki, Kedar
Publicado: (2015)

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
por: Arango, Jaime, et al.
Publicado: (2016)

Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
por: Rouse, Rodney, et al.
Publicado: (2017)

Indian Regulatory Update: January-December 2017
por: Bhave, Amita
Publicado: (2018)

Standardisation of defined approaches for skin sensitisation testing to support regulatory use and international adoption: position of the International Cooperation on Alternative Test Methods
por: Casati, S., et al.
Publicado: (2017)

Predicting in vivo effect levels for repeat-dose systemic toxicity using chemical, biological, kinetic and study covariates
por: Truong, Lisa, et al.
Publicado: (2017)

Cannot write session to /tmp/vufind_sessions/sess_v3so5bkltf0mn4oc96cnhk95cn