NELARABINE-REACH (Reach Pharmaceuticals Pty Ltd)
Product name
NELARABINE-REACH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
203 (255 working days)
Active ingredients
nelarabine
Registration type
NCE/NBE
Indication
Nelarabine is indicated for the treatment of patients with relapsing /refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment.
Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.