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LYNPARZA (olaparib)

Opinions on drugs - Posted on Dec 24 2019

Reason for request

New indication

  • Key points

Favourable opinion for reimbursement in the maintenance treatment of patients with advanced BRCA-mutated ovarian cancer who have responded to first-line chemotherapy[1].

  • What therapeutic improvement?

LYNPARZA provides a minor therapeutic improvement in the treatment of ovarian cancer.

  • Role in the care pathway?

The treatment of ovarian cancer is mainly based on initial surgery, followed by standard first-line chemotherapy for advanced-stage cancers. Some guidelines recommend the use of AVASTIN (bevacizumab) in combination with chemotherapy then as maintenance monotherapy in patients with a poor prognosis.

Role of the medicinal product in the care pathway

LYNPARZA is a maintenance treatment for adult patients with advanced BRCA-mutated ovarian cancer, who have responded to first-line platinum-based chemotherapy.

  • Special recommendations

The Committee reminds the fact that there are no data concerning the use of LYNPARZA as monotherapy in the maintenance treatment of patients treated with first-line chemotherapy combined with bevacizumab (AVASTIN).


Clinical Benefit

Substantial

The clinical benefit (CB) of LYNPARZA is substantial in the MA indication.

 


Clinical Added Value

minor

Considering:

  • the demonstrated superiority of olaparib in terms of progression-free survival assessed by the investigator compared to placebo (median not reached in the olaparib group vs 13.8 months in the placebo group; HR = 0.30; CI95% [0.23; 0.41]; p < 0.0001), without any demonstrated superiority on overall survival following the interim analysis scheduled in the protocol,
  • the absence of any formal conclusion that can be drawn based on the quality of life results,
  • the safety profile of olaparib, characterised primarily by gastrointestinal and haematological events and the absence of long-term safety data in a context in which this medicinal product can be administered as long-term treatment and cases of a malignant blood disorders have been reported, the Committee considers that LYNPARZA provides a minor clinical added value (CAV IV) in the care pathway for the treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

 

 


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