CAMBRIDGE, Mass. & BEIJING & HEMEL HEMPSTEAD, England--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ:BGNE; HKEX:06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory (R/R) neuroblastoma with or without residual disease. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA).
HEMEL HEMPSTEAD, England & BEIJING, China, & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA®? (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA) for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease. High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.
United Therap's Biological Dinutuximab Receives Approval In US
United Therapeutics Corporation (Nasdaq: UTHR) today announced topline results from the phase 2/3 DISTINCT clinical study evaluating Unituxin® (dinutuximab) Injection added to irinotecan compared to irinotecan or topotecan alone in patients with relapsed or refractory small cell lung cancer (SCLC). The DISTINCT trial did not meet its primary efficacy objective of extending the overall survival with Unituxin and irinotecan versus using irinotecan alone. The safety profile of dinutuximab in DISTINCT was consistent with prior studies and the current Unituxin product label.
A medicine used to treat a rare cancer that predominantly occurs in very young children is to be routinely funded on the NHS in Scotland.
Y-mAbs Therapeutics filed to raise up to $92 million in its IPO. The new capital will advance a clutch of monoclonal antibodies for childhood cancers including a pair of pivotal-stage meds for rare brain cancers through to regulatory submission.
EUSA Pharma today welcomed a decision from the National Institute of Health and Medical Demonstration (NICE) to recommend targeted anti-cancer immunotherapy drugs QARZIBA ® (dinutuximab Beta) for the treatment of high-risk neuroblastoma in children in England and Wales NHS