Press release

CHMP issues positive opinion on Type II variation to extend the therapeutic indication of Pepaxti based on OCEAN trial results

September 14, 2023 Regulatory

Stockholm — September 14, 2023 — Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has, following their scientific assessment, adopted a positive opinion on Oncopeptides’ application for earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM). The opinion from the CHMP will now be sent to the European Commission for a final decision.

Based on findings from its OCEAN trial, Oncopeptides submitted, on 28 Nov 2022, an application to extend the therapeutic indication of Pepaxti to the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy.

With their opinion, CHMP recommends that the use of Pepaxti could be expanded to earlier lines of treatment and also peripheral administration, meaning delivery of treatment through peripheral rather than central veins, a less invasive way of administration.

Oncopeptides will as a next step assess the current market dynamics of the rapidly evolving multiple myeloma landscape, including the competition in different lines of treatment and the effect that extending Pepaxti into earlier lines of treatment would have on Oncopeptides´ ability to receive a reimbursed price that reflects its innovation.

“The positive opinion from the CHMP further validates the scientific data on the efficacy, safety and increased quality of life that Pepaxti is able to bring to patients,” says Sofia Heigis, CEO of Oncopeptides. “While we are convinced that our drug best serves patients in later lines of treatment where the unmet need and our chances to receive a price that reflects our innovation are high, we will closely evaluate the CHMP opinion and our potential next steps, always keeping value for patients and our shareholders as paramount priorities.”

For more information, including a Q&A for investors, please visit Oncopeptides’ web site.