Selected EMA news, October 2025

New medicines approved

Vivlipeg (pegfilgrastim)
Treatment during cancer to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment

Wayrilz (rilzabrutinib)
Treatment of immune thrombocytopenia (when the body’s immune system destroys healthy platelets in the blood. Platelets are needed to form clots and stop bleeding)

Breyanzi (lisocabtagene maraleucel) – new indication
Treatment of different types of lymphoma (cancer of white blood cells)
Gazyvaro (obinutuzumab) – new indication – orphan
Treatment of chronic lymphocytic leukemia,  follicular lymphoma (both are cancers of B-lymphocytes, a type of white blood cell)
Pyrukynd (mitapivat) – new indication – orphan
Treatment of pyruvate kinase deficiency (an inherited disease that causes red blood cells to break down faster than normal) and anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia
Scemblix (asciminib) – change of indication – orphan
Treatment of chronic myeloid leukemia (a cancer of the white blood cells)

EMA has confirmed suspension of the sickle cell disease medicine Oxbryta.
EMA’s human medicines committee (CHMP) has recommended that the marketing authorization of Oxbryta remain suspended. This recommendation follows interim measures taken by the Committee in September 2024, when it temporarily suspended the medicine to review emerging safety data.

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