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2 Information about inavolisib plus palbociclib and fulvestrant

Marketing authorisation indication

2.1

Inavolisib (Itovebi, Roche) is indicated in combination with palbociclib and fulvestrant for 'the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist'.

Dosage in the marketing authorisation

Price

2.3

The list price of inavolisib is £5,418 per 28-pack of 3-mg tablets, and £10,836 per 28-pack of 9-mg tablets (excluding VAT; BNF online accessed May 2026).

2.4

Roche has a commercial arrangement for inavolisib, which would have applied if inavolisib with palbociclib and fulvestrant had been recommended.

2.5

Pfizer has a commercial arrangement for palbociclib. This makes palbociclib available to the NHS with a discount and it would have also applied to this indication if inavolisib with palbociclib and fulvestrant had been recommended. The size of the discount is commercial in confidence.

Sustainability