(Cytarabine hydrochloride + daunorubicin hydrochloride) is under clinical development by Jazz Pharmaceuticals and currently in Phase II for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Relapsed Acute Myeloid Leukemia have a 20% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Cytarabine hydrochloride + daunorubicin hydrochloride)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(Cytarabine hydrochloride + daunorubicin hydrochloride) overview

Cytarabine hydrochloride and daunorubicin hydrochloride (Vyxeos) is a fixed dose combination drug, acts as anti cancer agent. It is formulated as lyophilized cake or injectable liposomal concentrate suspension for intravenous route of administration. Vyxeos is indicated for the treatment of adults with newly-diagnosed therapy-related acutemyeloid leukemia(t-AML) or AML with myelodysplasia-related changes (AML-MRC).

CPX-351 is under development for the treatment of Myelodysplastic Syndrome relapsed acute myeloid leukemia, acute myeloid leukemia as first line treatment in adults and pediatric patients, myelodysplastic syndrome, t-cell acute lymphoblastic leukemia and aggressive lymphoma. It was also under development for relapsed or refractory acute lymphoblastic leukemia, refractory acute myeloid leukemia and chronic myelomonocytic leukemia.

Jazz Pharmaceuticals overview

Jazz Pharmaceuticals is a specialty biopharmaceutical company which identifies, develops, and commercializes medicines with focus on narcolepsy, cancer, pain, and psychiatry. Its marketed products include Xyrem (sodium oxybate) oral solution, Sunosi (solriamfetol), Erwinaze (asparaginase erwinia chrysanthemi), Defitelio (defibrotide sodium), Vyxeos (daunorubicin and cytarabine) liposome for injection, and others. The company also has various pipeline product candidates related to focus areas such as sleep, neurological disorders, hematology, and oncology including hematologic malignancies and solid tumors. The company sells its products through a network of local distributors and wholesalers. It has operations in the US and Europe. Jazz Pharmaceuticals is headquartered in Dublin, Ireland.

For a complete picture of (Cytarabine hydrochloride + daunorubicin hydrochloride)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.