Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Status: Opinion
Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Status: Opinion
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cavoley, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.
The applicant for this medicinal product is CuraTeQ Biologics s.r.o.
Cavoley will be available as 6 mg solution for injection in pre-filled syringes. The active substance of Cavoley is pegfilgrastim, an immunostimulant, colony-stimulating factor (ATC code: L03AA13) which stimulates the development and differentiation of mature and functionally active neutrophils from precursor cells in the bone marrow.
Cavoley is a biosimilar medicinal product. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data show that Cavoley has comparable quality, safety and efficacy to Neulasta (pegfilgrastim).
The full indication is:
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Cavoley should be initiated and supervised by physicians experienced in oncology and/or haematology.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Cavoley
Reference Number:
EMADOC-1829012207-59658
English (EN) (131.96 KB - PDF)
First published:
24/07/2026
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Product details
Name of medicine
Cavoley
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA13
EMA product number
EMEA/H/C/006937
Biosimilar
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.
Marketing authorisation applicant
CuraTeQ Biologics s.r.o
Opinion adopted
23/07/2026
Opinion status
Positive
News on Cavoley
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026
24/07/2026
This page was last updated on
24/07/2026
Summary
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cavoley, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is CuraTeQ Biologics s.r.o. Cavoley will be available as 6 mg solution for injection in pre-filled syringes. The active substance of Cavoley is pegfilgrastim, an immunostimulant, colony-stimulating factor (ATC code: L03AA13) which stimulates the development and differentiation of mature and functionally active neutrophils from precursor cells in the bone marrow. Cavoley is a biosimilar medicinal product. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data show that Cavoley has comparable quality, safety and efficacy to Neulasta (pegfilgrastim). The full indication is: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Cavoley should be initiated and supervised by physicians experienced in oncology and/or haematology. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.