Palazestrant Medicine 04 December 2025 Extended indication Palazestrant monotherapy for second line or later treatment of locally advanced or metastatic hormone receptor positive HER2 negative breast cancer in adults and elderly whose disease has advanced on a endocrine therapy in combination with a CDK4/6 inhibitor. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Palazestrant Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Palazestrant monotherapy for second line or later treatment of locally advanced or metastatic hormone receptor positive HER2 negative breast cancer in adults and elderly whose disease has advanced on a endocrine therapy in combination with a CDK4/6 inhibitor. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Olema Portfolio holder Olema Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. FDA Fast Track designation. Therapeutic value Current treatment options Fulvestrant Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie is nog gaande. Duration of treatment Frequency of administration 1 times a day Dosage per administration 90 of 120mg References NCT06016738 (OPERA-01) Additional remarks 120mg of 90mg eenmaal daags in een cyclus van vier weken (28 dagen) Expected patient volume per year Patient volume < 2,974 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks In 2024 waren er 2.974 gebruikers van fulvestrant. Dit is het patiëntvolume dat mogelijk in aanmerking komt voor palazestrant. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks