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KADCYLA (Roche Products Pty Ltd)

Product name
KADCYLA
Sponsor
Roche Products Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
105 working days (255)
Active ingredients
trastuzumab emtansine (rch)
Registration type
EOI
Indication
Early breast cancer

KADCYLA (powder for injection), as a single agent, is now also indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Registration process

Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

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