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AIFA's September innovative medicines update adds no new designations; Blenrep and Itovebi denied status

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency recorded no new innovativeness recognitions for September 2026, while confirming that belantamab mafodotin and inavolisib were refused the status for their assessed indications.

AIFA published its monthly update of the list of medicines judged by its Scientific and Economic Commission (CSE) to meet the requirement of therapeutic innovativeness on 30 October 2026, covering the period to 30 September. The agency also makes available the evaluation reports behind each innovativeness decision, by therapeutic indication.

For September, AIFA reported no new determinations granting innovative status. It did, however, flag two products for which the requirement was not recognised: Blenrep (belantamab mafodotin) and Itovebi (inavolisib).

The Blenrep decision concerns its use in adults with relapsed or refractory multiple myeloma. The indications cited are in combination with bortezomib and dexamethasone after at least one prior therapy, and in combination with pomalidomide and dexamethasone after at least one prior therapy that included lenalidomide.

The Itovebi decision relates to its use with palbociclib and fulvestrant in adults with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer that has relapsed during or within 12 months of completing adjuvant endocrine therapy. The cited wording also covers a 12-month interval requirement after prior CDK4/6 inhibitor treatment in the (neo)adjuvant setting, and LHRH agonist use in pre/perimenopausal women and in men.

AIFA separately noted that its list of anti-infective agents for multidrug-resistant infections had no September updates, as no determinations were published on eligibility for the Innovative Medicines Fund. In Italy, innovative status is relevant to market access because it is tied to dedicated funding and expedited regional availability.

What it means for your team

  • Market-access teams should note that Blenrep and Itovebi will not benefit from innovative status for the indications assessed, which is relevant to Italian funding and regional-availability planning.
  • No new innovative designations were recorded for September, so existing list entries are unchanged for this period.
  • Companies with products under assessment can consult the published CSE evaluation reports to understand how innovativeness decisions are reasoned per indication.
  • No anti-infective determinations on Innovative Medicines Fund access were published for September.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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