FDA approval summary: palbociclib for male patients with metastatic breast cancer
S Wedam, L Fashoyin-Aje, E Bloomquist, S Tang… - Clinical Cancer …, 2020 - AACR
Abstract On April 4, 2019, the FDA approved a supplemental new drug application for
palbociclib (IBRANCE), to expand the approved indications in women with hormone …
palbociclib (IBRANCE), to expand the approved indications in women with hormone …
FDA approval of palbociclib in combination with fulvestrant for the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer
AJ Walker, S Wedam, L Amiri-Kordestani… - Clinical Cancer …, 2016 - AACR
Abstract On February 19, 2016, the FDA approved palbociclib (Ibrance, Pfizer) for use in
combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women with …
combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women with …
Real-world clinical outcomes and toxicity in metastatic breast cancer patients treated with palbociclib and endocrine therapy
L Varella, AS Eziokwu, X Jia, M Kruse… - Breast cancer research …, 2019 - Springer
Purpose Real-world data are critical to demonstrate the reproducibility of evidence and
external generalizability of randomized clinical trials. Palbociclib is an oral small-molecule …
external generalizability of randomized clinical trials. Palbociclib is an oral small-molecule …
FDA approval: palbociclib for the treatment of postmenopausal patients with estrogen receptor–positive, HER2-negative metastatic breast cancer
JA Beaver, L Amiri-Kordestani, R Charlab, W Chen… - Clinical Cancer …, 2015 - AACR
Abstract On February 3, 2015, the FDA granted accelerated approval to palbociclib
(IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) …
(IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) …
Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for HR+/HER2-advanced breast cancer
V Diéras, HS Rugo, P Schnell, K Gelmon… - JNCI: Journal of the …, 2019 - academic.oup.com
Background Palbociclib administered with endocrine therapy was tolerable when the overall
incidence of toxicities was assessed separately for three PALOMA studies. This study …
incidence of toxicities was assessed separately for three PALOMA studies. This study …
Palbociclib: first global approval
S Dhillon - Drugs, 2015 - Springer
Palbociclib (Ibrance®) is an oral, reversible, selective, small-molecule inhibitor of cyclin-
dependent kinases (CDK) 4 and CDK6 developed by Pfizer for the treatment of cancer …
dependent kinases (CDK) 4 and CDK6 developed by Pfizer for the treatment of cancer …
[HTML][HTML] Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative …
Background The activity of palbociclib as a single agent in advanced breast cancer has not
been extensively studied, with the only available clinical data limited to heavily pretreated …
been extensively studied, with the only available clinical data limited to heavily pretreated …
Palbociclib in combination with fulvestrant in women with hormone receptor-positive/HER2-negative advanced metastatic breast cancer: detailed safety analysis from …
S Verma, CH Bartlett, P Schnell, AM DeMichele… - The …, 2016 - academic.oup.com
Background. Palbociclib enhances endocrine therapy and improves clinical outcomes in
hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative …
hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative …
Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative …
G Taylor-Stokes, D Mitra, J Waller, K Gibson, G Milligan… - The Breast, 2019 - Elsevier
Purpose Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor approved for
use in postmenopausal women with hormone receptor-positive, human epidermal growth …
use in postmenopausal women with hormone receptor-positive, human epidermal growth …
Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2 …
RS Finn, K Boer, I Bondarenko, R Patel, T Pinter… - Breast cancer research …, 2020 - Springer
Purpose Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in
combination with endocrine therapy for the treatment of women and men with hormone …
combination with endocrine therapy for the treatment of women and men with hormone …
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