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DECAPEPTYL LP 3 mg (triptorelin), GnRH analogue

ONCOLOGY - New indication
Opinions on drugs - Posted on Feb 20 2019

Reason for request

Extension of indication

Insufficient clinical benefit to justify its reimbursement, in combination with tamoxifen or with an aromatase inhibitor, for the adjuvant treatment of hormone-sensitive breast cancer in non-menopausal women at high risk of relapse, after chemotherapy.

 

  • DECAPEPTYL (triptorelin) LP 3 mg has been granted a marketing authorisation, in combination with tamoxifen or with an aromatase inhibitor, for the adjuvant treatment of hormone-sensitive breast cancer in non-menopausal women at high risk of relapse, after chemotherapy.

  • Triptorelin is a natural GnRH (gonadotropin releasing hormone) analogue that suppresses oestrogen synthesis by the ovaries. Suppression of ovarian function, combined with tamoxifen, causes increased toxicity relative to tamoxifen alone.

  • One study demonstrated the absence of benefit in terms of 5-year disease-free survival of ovarian function suppression (in particular by triptorelin) combined with tamoxifen compared to tamoxifen alone.

  • DECAPEPTYL LP 3 mg has no role in the current management strategy for early stage hormone-sensitive breast cancer in non-menopausal women, a strategy which is based on tamoxifen used alone.

 

 


Clinical Benefit

Insufficient

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Clinical Added Value

Not applicable

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