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AIFA's September innovative medicines update adds none, and rejects innovative status for Blenrep and Itovebi

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency recorded no new innovativeness recognitions for September 2026 and named two oncology products that failed to meet the criterion.

AIFA published its monthly update of the list of medicines judged by its Scientific and Economic Commission (CSE) to have therapeutic innovativeness, current to 30 September 2026. The notice appeared on 30 October 2026. AIFA also makes available the assessment reports behind each innovativeness decision, indication by indication.

For September, the agency reports no new determinations granting innovative status. The month's update instead highlights two products for which the criterion was not recognised.

The first is Blenrep (belantamab mafodotin), for adults with relapsed or refractory multiple myeloma. The assessed indications cover use with bortezomib and dexamethasone in patients with at least one prior therapy, and use with pomalidomide and dexamethasone in patients who have had at least one prior therapy including lenalidomide.

The second is Itovebi (inavolisib), assessed for use with palbociclib and fulvestrant in adults with PIK3CA-mutated, ER-positive, HER2-negative locally advanced or metastatic breast cancer. It applies after recurrence during or within 12 months of completing adjuvant endocrine therapy. The wording requires a gap of at least 12 months between stopping a prior CDK4/6 inhibitor in the (neo)adjuvant setting and recurrence. In pre- or perimenopausal women and in men, endocrine therapy must be combined with an LHRH agonist.

AIFA adds that there were also no September determinations on anti-infective agents for multidrug-resistant infections that had been assessed for access to the Innovative Medicines Fund. The notice does not give reasons for the two negative outcomes.

What it means for your team

  • Market-access teams should note that Blenrep and Itovebi did not obtain innovative status for the indications assessed, so any access or funding plans should not assume it.
  • No new innovative designations were recorded for September 2026, so the existing list is unchanged by this update.
  • The assessment reports published by AIFA are the place to look for the detailed rationale, as the news notice itself gives none.
  • No anti-infective determinations for the Innovative Medicines Fund were published for the month.

Official source: AIFA ↗

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

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