TY - JOUR
T1 - FDA approval of palbociclib in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer
AU - Walker, Amanda J.
AU - Wedam, Suparna
AU - Amiri-Kordestani, Laleh
AU - Bloomquist, Erik
AU - Tang, Shengui
AU - Sridhara, Rajeshwari
AU - Chen, Wei
AU - Palmby, Todd R.
AU - Zirkelbach, Jeanne Fourie
AU - Fu, Wentao
AU - Liu, Qi
AU - Tilley, Amy
AU - Kim, Geoffrey
AU - Kluetz, Paul G.
AU - McKee, Amy E.
AU - Pazdur, Richard
N1 - Publisher Copyright:
©2016 AACR.
PY - 2016/10/15
Y1 - 2016/10/15
N2 - On February 19, 2016, the FDA approved palbociclib (Ibrance, Pfizer) for use in combination with fulvestrant (Faslodex, Astra-Zeneca) for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy. The approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 521 pre- and postmenopausal women with HR-positive, HER2-negative advanced or MBC. Patients were randomized (2:1) to receive palbociclib plus fulvestrant (n = 347) or placebo plus fulvestrant (n = 174). The primary endpoint was investigator-assessed progression-free survival (PFS). A statistically significant and clinically meaningful improvement in PFS (9.5 months vs. 4.6 months) was observed in patients receiving palbociclib plus fulvestrant [HR 0.46; 95% confidence interval (CI), 0.36-0.59; P < 0.0001]. Safety data confirmed the known adverse reaction profile of palbociclib. The most common adverse reactions (>20%) in patients treated with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, and thrombocytopenia. This approval was granted in the context of a prior accelerated approval for palbociclib in combination with letrozole in patients with HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy.
AB - On February 19, 2016, the FDA approved palbociclib (Ibrance, Pfizer) for use in combination with fulvestrant (Faslodex, Astra-Zeneca) for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy. The approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 521 pre- and postmenopausal women with HR-positive, HER2-negative advanced or MBC. Patients were randomized (2:1) to receive palbociclib plus fulvestrant (n = 347) or placebo plus fulvestrant (n = 174). The primary endpoint was investigator-assessed progression-free survival (PFS). A statistically significant and clinically meaningful improvement in PFS (9.5 months vs. 4.6 months) was observed in patients receiving palbociclib plus fulvestrant [HR 0.46; 95% confidence interval (CI), 0.36-0.59; P < 0.0001]. Safety data confirmed the known adverse reaction profile of palbociclib. The most common adverse reactions (>20%) in patients treated with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, and thrombocytopenia. This approval was granted in the context of a prior accelerated approval for palbociclib in combination with letrozole in patients with HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy.
UR - http://www.scopus.com/inward/record.url?scp=84991720124&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84991720124&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-16-0493
DO - 10.1158/1078-0432.CCR-16-0493
M3 - Article
C2 - 27407089
AN - SCOPUS:84991720124
SN - 1078-0432
VL - 22
SP - 4968
EP - 4972
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 20
ER -