№ files_lp_4_process_3_086058
Year: 2015
Region / City: Australia
Topic: Pharmaceutical drug application
Document type: Drug submission
Organization: TGA, PBAC
Author: AMGEN
Target Audience: Pharmaceutical regulators, healthcare professionals
Period of validity: Not specified
Approval date: October 2015
Amendment date: Not specified
Treatment: Relapsed or refractory B-precursor acute lymphoblastic leukaemia (Ph-)
Proposed use: Inpatient hospital setting
Cost: Not specified
Clinical trial: MT103-211
Guideline reference: National Comprehensive Cancer Network (NCCN) Version 2.2014
Indication: Orphan drug designation
Comparator: Standard of care chemotherapy regimens (FLAG, High-dose methotrexate, HiDAC)
Price: 8 / 10 USD
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