PMID- 34213061
OWN - NLM
STAT- MEDLINE
DCOM- 20211221
LR  - 20211221
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 26
IP  - 11
DP  - 2021 Nov
TI  - EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for 
      the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma.
PG  - 983-987
LID - 10.1002/onco.13892 [doi]
AB  - Isatuximab is a monoclonal antibody that binds to the human CD38 antigen. On May 
      30, 2020, a marketing authorization valid through the European Union (EU) was 
      issued for isatuximab in combination with pomalidomide and dexamethasone (IsaPd) 
      for the treatment of adult patients with relapsed and refractory (RR) multiple 
      myeloma (MM). The recommended dose of isatuximab was 10 mg/kg, administered 
      intravenously weekly at cycle 1 and then biweekly in subsequent 28-day cycles. 
      Isatuximab was evaluated in a phase III, open-label, multicenter, randomized 
      trial that randomly allocated IsaPd versus pomalidomide plus dexamethasone (Pd) 
      to adult patients with RR MM. The primary endpoint of the trial was 
      progression-free survival, as assessed by an independent review committee, which 
      was superior for the IsaPd arm (hazard ratio, 0.596; 95% confidence interval, 
      0.436-0.814; p = .001) compared with the Pd arm. Treatment with IsaPd led to 
      higher incidences of treatment-related adverse events (AEs), grade >/= 3 AEs, and 
      serious AEs compared with Pd treatment. Most frequently observed AEs that 
      occurred more often in the IsaPd arm were infusion-related reactions, infections, 
      respiratory AEs, neutropenia (including neutropenic complications), and 
      thrombocytopenia. The aim of this article is to summarize the scientific review 
      of the application leading to regulatory approval in the EU. IMPLICATIONS FOR 
      PRACTICE: Isatuximab was approved in the European Union, in combination with 
      pomalidomide and dexamethasone, for the treatment of patients with multiple 
      myeloma who have already received therapy but whose disease did not respond or 
      relapsed afterward. The addition of isatuximab resulted in a clinically 
      meaningful and significant prolongation of the time from treatment initiation to 
      further disease relapse or patient's death. The safety profile was considered 
      acceptable, and the benefit-risk ratio was determined to be positive.
CI  - (c) 2021 AlphaMed Press.
FAU - Delgado, Julio
AU  - Delgado J
AUID- ORCID: 0000-0002-5157-4376
AD  - Oncology and Hematology Office, European Medicines Agency, Amsterdam, The 
      Netherlands.
AD  - Department of Hematology, Hospital Clinic, Barcelona, Spain.
FAU - Zienowicz, Malgorzata
AU  - Zienowicz M
AD  - Oncology and Hematology Office, European Medicines Agency, Amsterdam, The 
      Netherlands.
FAU - van Hennik, Paula Boudewina
AU  - van Hennik PB
AD  - Committe for Medicinal Products for Human Use, European Medicines Agency, 
      Amsterdam, The Netherlands.
AD  - College ter Beoordeling van Geneesmiddelen, Utrecht, The Netherlands.
FAU - Moreau, Alexandre
AU  - Moreau A
AD  - Committe for Medicinal Products for Human Use, European Medicines Agency, 
      Amsterdam, The Netherlands.
AD  - Agence Nationale de Securite du Medicament et des Produits de Sante, Saint-Denis, 
      France.
FAU - Gisselbrecht, Christian
AU  - Gisselbrecht C
AD  - Hopital Saint Louis, Paris, France.
FAU - Enzmann, Harald
AU  - Enzmann H
AD  - Committe for Medicinal Products for Human Use, European Medicines Agency, 
      Amsterdam, The Netherlands.
AD  - Bundesinstitut fur Arzneimittel und Medizinprodukte, Bonn, Germany.
FAU - Pignatti, Francesco
AU  - Pignatti F
AD  - Oncology and Hematology Office, European Medicines Agency, Amsterdam, The 
      Netherlands.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210719
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - D2UX06XLB5 (pomalidomide)
RN  - R30772KCU0 (isatuximab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized
MH  - Dexamethasone
MH  - Humans
MH  - *Multiple Myeloma/drug therapy
MH  - *Neutropenia
MH  - Thalidomide/analogs & derivatives
PMC - PMC8571773
OTO - NOTNLM
OT  - Dexamethasone
OT  - EMA * Anti-CD38 antibody
OT  - Isatuximab
OT  - Multiple myeloma
OT  - Pomalidomide
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2021/07/03 06:00
MHDA- 2021/12/22 06:00
PMCR- 2021/11/01
CRDT- 2021/07/02 09:10
PHST- 2021/02/24 00:00 [received]
PHST- 2021/06/23 00:00 [accepted]
PHST- 2021/07/03 06:00 [pubmed]
PHST- 2021/12/22 06:00 [medline]
PHST- 2021/07/02 09:10 [entrez]
PHST- 2021/11/01 00:00 [pmc-release]
AID - ONCO13892 [pii]
AID - 10.1002/onco.13892 [doi]
PST - ppublish
SO  - Oncologist. 2021 Nov;26(11):983-987. doi: 10.1002/onco.13892. Epub 2021 Jul 19.