Empliciti

elotuzumab

Opinion

On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Empliciti. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a new indication as follows:

“Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).”

For information, the full indications for Empliciti will be as follows:1

“Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).

Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Key facts

Name
Empliciti
Agency product number
EMEA/H/C/003967
International non-proprietary name (INN) or common name
  • elotuzumab
Active substance
  • Elotuzumab
Therapeutic area
Multiple Myeloma
Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
25/07/2019
Company name
Bristol-Myers Squibb Pharma EEIG
Status
Positive
Application type
Post-authorisation

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