34 / 36
FDA grants regular approval to pertuzumab for
adjuvant treatment of HER2-positive breast cancer
On December 20, 2017, the Food and Drug
Administration granted regular approval to pertuzumab
(PERJETA, Genentech, Inc.) for use in combination
with trastuzumab and chemotherapy as adjuvant
treatment of patients with HER2-positive early breast
cancer at high risk of recurrence.
Approval was based on data from APHINITY
(NCT01358877)
“ aprobación acelerada a aprobación completa”