AIFA Innovative Drugs April 2026: Opdivo, Yervoy, Rybrevant, Carvykti Lead New Additions | Italy Pharma | News | iPharmaCenter
- Badari Andukuri
- 6 hours ago
- 2 min read
The Italian Medicines Agency (AIFA) has issued an updated overview of medicinal products and anti-infective therapies recognized for their level of therapeutic advancement as of April 30, 2026. These updates are based on assessments conducted by the Scientific and Economic Commission, which determines whether a medicine qualifies as therapeutically innovative.
Medicines Granted Innovative Status in Italy in April 2026
The latest update includes several therapies that have been officially classified as innovative:
Opdivo (nivolumab): Approved in combination with ipilimumab for first-line treatment of adult patients with unresectable or metastatic colorectal cancer characterized by mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).
Yervoy (ipilimumab): Authorized for use alongside nivolumab in the same first-line setting for adults with dMMR or MSI-H metastatic or inoperable colorectal cancer.
Rybrevant (amivantamab): Indicated in combination with carboplatin and pemetrexed for the initial treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Carvykti (ciltacabtagene autoleucel): Approved for adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy, including both an immunomodulatory agent and a proteasome inhibitor, and whose disease has progressed with resistance to lenalidomide.
Official references supporting inclusion in the innovative medicines list are available through AIFA determinations published on the “TrovaNormeFarmaco” portal, with additional details accessible via notices in the Official Journal.
Products Not Meeting Innovation Criteria in Italy
AIFA has also disclosed evaluation reports for therapies that did not meet the criteria for therapeutic innovation:
Lazcluze (lazertinib): Assessed in combination with amivantamab for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.
Rybrevant (amivantamab): Evaluated alongside lazertinib for the same NSCLC indication involving EGFR exon 19 or exon 21 mutations.
Spevigo (spesolimab): Reviewed for its role in preventing flare-ups of generalized pustular psoriasis (GPP) in patients aged 12 years and older.
Yorvipath (palopegteriparatide): Considered for use as a parathyroid hormone replacement in adults with chronic hypoparathyroidism not adequately managed with standard therapies.
Alhemo (concizumab): Evaluated for routine prevention of bleeding episodes in patients aged 12 years and above with haemophilia B and factor IX inhibitors.
Anti-Infective Agents Update in Italy
AIFA has also refreshed its list of anti-infective treatments targeting infections caused by multidrug-resistant organisms, aligned with the World Health Organization’s AWaRe (Access, Watch, Reserve) classification system. These agents fall under the “Reserve” category and demonstrate activity against at least one high-priority pathogen identified in the WHO Bacterial Priority Pathogens List.
Although these anti-infective drugs are not evaluated for innovativeness, their use in treating resistant infections is closely tracked through AIFA’s monitoring registry. Additionally, they are eligible for reimbursement under the Innovative Medicines Fund when prescribed for such indications.
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