European Commission expands Oncopeptides' Pepaxti authorisation to third-line multiple myeloma

The European Commission has approved an expansion of Oncopeptides' Pepaxti label into third-line multiple myeloma treatment, broadening eligibility after two prior lines of therapy and removing the previous triple-class refractory requirement.

Oncopeptides announced on 9 November 2026 that the European Commission had approved a Type II variation extending the authorised use of Pepaxti (melphalan flufenamide) with dexamethasone to eligible adults with multiple myeloma after at least two prior treatment lines whose disease is refractory to lenalidomide and their last line of treatment, subject to the full approved product information.

The decision shifts Pepaxti's European treatment positioning from fourth-line to third-line use and removes the earlier triple-class refractory requirement, potentially expanding the eligible patient population; Oncopeptides estimates the addressable European market could approximately double, although that projection is not evidence of actual patient uptake or commercial sales.

Field	Content
Article Type	Approvals
Company	Oncopeptides
Product	Pepaxti
Active Ingredient	Melphalan flufenamide
Combination Medicine	Dexamethasone
Regulatory Authority	European Commission
Announcement Date	9 November 2026
Regulatory Decision	Marketing authorisation label expansion
Variation Type	Type II variation
Geographic Scope	European Union
Therapeutic Area	Haematology and oncology
Disease	Multiple myeloma
Patient Population	Eligible adults with multiple myeloma meeting the revised authorised treatment criteria
Minimum Prior Treatment Lines	At least two
Refractory Disease Requirement One	Refractory to lenalidomide
Refractory Disease Requirement Two	Refractory to the last line of therapy
New Treatment Position	Third-line treatment
Previous Treatment Position	Fourth-line treatment
Previous Triple-Class Refractory Requirement	Removed under the expanded authorisation
Treatment Regimen	Pepaxti in combination with dexamethasone
Previous Regulatory Step	September 2026 CHMP opinion
Final Regulatory Step	European Commission approval
First European Authorisation	No
New CHMP Opinion	No; final EC decision follows the earlier opinion
Estimated Change in Addressable Patient Population	Potentially approximately double
Market Expansion Estimate Source	Oncopeptides
Market Expansion Estimate Status	Company projection rather than observed treatment uptake
Commercial Sales Impact	Not yet established
What Happened	The European Commission approved broader Pepaxti eligibility for eligible patients with relapsed or refractory multiple myeloma.
Why It Matters	The expanded label potentially makes the treatment available earlier in the multiple myeloma treatment pathway.
Clinical Significance	The authorisation reduces the number of required previous treatment lines and removes the former triple-class refractory restriction.
Commercial Significance	Oncopeptides anticipates a substantially larger eligible European patient population.
Regulatory Clarification	This is a final European Commission label expansion rather than a new product authorisation or CHMP recommendation.
Key Takeaway	Pepaxti can be used in an expanded third-line European multiple myeloma population subject to the full authorised label.
What to Watch	Country-level reimbursement, clinical adoption, patient access, European sales and real-world outcomes.
Primary Source	Oncopeptides
Primary Source URL	https://oncopeptides.com/press-releases/european-commission-approves-label-expansion-of-pepaxti-to-third-line-treatment/
Submitted Source	BioStock
Submitted Source URL	https://biostock.se/en/2026/11/oncopeptides-om-eu-godkannandet-som-flyttar-pepaxti-till-tredje-linjen/
Relevant Date	9 November 2026

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