ARTICLE | Clinical News
Isqette regulatory update
March 31, 2017 5:16 AM UTC
EMA's CHMP recommended approval of an MAA from Apeiron for Isqette dinutuximab beta to treat high-risk neuroblastoma under EMA's exceptional circumstances clause. It is recommended in patients ages ≥12 months who achieved a partial response after induction chemotherapy, followed by myeloablative therapy and stem cell transplantation. It is also recommended in patients with relapsed or refractory neuroblastoma. Apeiron expects a decision by the European Commission within 2 months...
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