EMA: Lynparza (olaparib): CHMP positive opinion - nuova indicazione in BCa

Lo scorso 23 Giugno 2022, il CHMP ha adottato una positive opinion relativa all'aggiunta di una nuova indicazione terapeutica nel setting del trattamento adiuvante nei pazienti adulti affetti da BCa precoce ad alto rischio con mutazioni BRCA1/2, HER2-, alto rischio, trattati con chemioterapia in neoadiuvante ed adiuvante.

Riportiamo qui di seguito la sezione delle indicazioni relative al BCa, con in grassetto la nuova indicazione.

Breast cancer

Lynparza is indicated as:

• monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).
• monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.