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CCR Perspectives in Drug Approval

The European Medicines Agency Review of Eribulin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

Elias Pean, Sigrid Klaar, Eva Gil Berglund, Tomas Salmonson, Jeanett Borregaard, Kenneth F. Hofland, Jens Ersbøll, Eric Abadie, Rosa Giuliani and Francesco Pignatti
Elias Pean
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Sigrid Klaar
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Eva Gil Berglund
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Tomas Salmonson
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Jeanett Borregaard
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Kenneth F. Hofland
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Jens Ersbøll
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Eric Abadie
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Rosa Giuliani
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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Francesco Pignatti
Authors' Affiliations: 1European Medicines Agency, London, United Kingdom; 2Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; 3Lægemiddelstyrelsen, Danish Medicines Agency, Copenhagen, Denmark;and 4Agence française de sécurite sanitaire des produits de santé (French Agency for the Safety of Health Products), Saint-Denis, France
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DOI: 10.1158/1078-0432.CCR-11-3075 Published September 2012
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    Figure 1.

    Chemical structure and numbering system of eribulin. Image courtesy of EMA European public assessment report for Halaven. Structural formula of eribulin mesylate (E7389).

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    Figure 2.

    Overall survival: Kaplan–Meier estimates of the survival function by treatment group for the data from the updated analysis (intent-to-treat population). Image courtesy of EMA European public assessment report for Halaven.

Tables

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  • Table 1.

    Summary of selected baseline characteristics (ITT population: study 305)

    Treatment groupTotal
    ParameterEribulin N = 508, n (%)TPC N = 254, n (%)N = 762, n (%)
    Time since original diagnosis, y
     Median5.45.15.2
    Tumor sites in >10% patients overall, n (%)
     Bone306 (60.2)158 (62.2)464 (60.9)
     Liver296 (58.3)159 (62.6)455 (59.7)
     Lymph nodes220 (43.3)118 (46.5)338 (44.4)
     Lung197 (38.8)95 (37.4)292 (38.3)
     Pleura87 (17.1)42 (16.5)129 (16.9)
     Breast54 (10.6)24 (9.4)78 (10.2)
    Number of organs involved, n (%)a
     185 (16.7)35 (13.8)120 (15.7)
     2172 (33.9)82 (32.3)254 (33.3)
     3145 (28.5)77 (30.3)222 (29.1)
     471 (14.0)37 (14.6)108 (14.2)
     524 (4.7)16 (6.3)40 (5.2)
     ≥69 (1.8)7 (2.8)16 (2.1)
    HER2/neu status (combined FISH and IHC tests), n (%)b
     Positive83 (16.3)40 (15.7)123 (16.1)
     Negative373 (73.4)192 (75.6)565 (74.1)
     Unknown4 (0.8)0 (0)4 (0.5)
     Not done48 (9.4)22 (8.7)70 (9.2)
    ER status, n (%)
     Positive336 (66.1)171 (67.3)507 (66.5)
     Negative143 (28.1)72 (28.3)215 (28.2)
     Unknown1 (0.2)0 (0)1 (0.1)
     Not done28 (5.5)11 (4.3)39 (5.1)
    PgR status, n (%)
     Positive254 (50.0)123 (48.4)377 (49.5)
     Negative197 (38.8)102 (40.2)299 (39.2)
     Unknown1 (0.2)0 (0)1 (0.1)
     Not done56 (11.0)29 (11.4)85 (11.2)
    Negative for ER, PgR, and HER2/neu, n (%)
     Yes93 (18.3)51 (20.1)144 (18.9)
     No380 (74.8)192 (75.6)572 (75.1)
     Unknownc35 (6.9)11 (4.3)46 (6.0)
    Cancer stage at diagnosis
     02 (0.4)0 (0)2 (0.3)
     I62 (12.2)30 (11.8)92 (12.1)
     II213 (41.9)89 (35.0)302 (39.6)
     III142 (28.0)71 (28.0)213 (28.0)
     IV81 (15.9)59 (23.2)140 (18.4)
     Not available8 (1.6)5 (2.0)13 (1.7)

    Abbreviations: ER, estrogen receptor; HER2/neu, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ITT, intent to treat; PgR, progesterone receptor.

    • ↵aThe number of organs involved is based on the local evaluation.

    • ↵bFor patients who were tested with FISH their status is derived from the FISH test irrespective of IHC results even if the FISH test yielded a result of unknown. Results from the IHC tests are used only when the FISH test was not conducted. For these patients, a result of 3+ indicates that the patient was Her2/neu positive.

    • ↵cIncludes patients whose results were ER and PgR negative and who were never tested for their Her2 status (n = 26 and 10 for eribulin and TPC, respectively).

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Clinical Cancer Research: 18 (17)
September 2012
Volume 18, Issue 17
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The European Medicines Agency Review of Eribulin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use
Elias Pean, Sigrid Klaar, Eva Gil Berglund, Tomas Salmonson, Jeanett Borregaard, Kenneth F. Hofland, Jens Ersbøll, Eric Abadie, Rosa Giuliani and Francesco Pignatti
Clin Cancer Res September 1 2012 (18) (17) 4491-4497; DOI: 10.1158/1078-0432.CCR-11-3075

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The European Medicines Agency Review of Eribulin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use
Elias Pean, Sigrid Klaar, Eva Gil Berglund, Tomas Salmonson, Jeanett Borregaard, Kenneth F. Hofland, Jens Ersbøll, Eric Abadie, Rosa Giuliani and Francesco Pignatti
Clin Cancer Res September 1 2012 (18) (17) 4491-4497; DOI: 10.1158/1078-0432.CCR-11-3075
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