FDA approves dose escalation licence extension for neratinib in HER2-positive early stage and metastatic breast cancer
Dose escalation (DE) schedule (120mg/d wk 1, 160mg/d wk 2, 240mg/d wk 3 & thereafter for duration of treatment, with loperamide prophylaxis [PX]) is based on phase II CONTROL trial which showed greater reduction in diarrhoea and discontinuation rates vs no DE or antidiarrheal PX.
Source:
Biospace Inc.
SPS commentary:
A new bottle containing 4 week supply of 133 tablets, is aligned with this schedule.
In UK, the current recommended dose is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year. Dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions may require dose interruption and/or dose reduction as detailed in SPC.