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Ribociclib FDA label updated to include pre- and perimenopausal women

On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis)  approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised

Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2018 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.

FDA approved abemaciclib plus aromatase inhibitor for untreated postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer

 

esmo 2016 breast cancer ribociclib palbociclib abemaciclib data medipaper medicall writer

ESMO16 Breast Cancer: Palbociclib, Ribociclib and Abemaciclib Data

Cyclin-dependent Kinase 4 and 6 (CDK4/6) inhibitors have shown clinical activity in patients with endocrine-resistant metastatic breast cancer. During the European Society for Medical Oncology (ESMO) Annual Meeting 2016, significant updates on studies with CDK4/6 inhibitors ribociclib, palbociclib and abemaciclib were presented.

palbociclib-first-in-class

Palbociclib (Ibrance®): First in Class CDK4/6 Inhibitor

At the American Association for Cancer Research, 2014 annual meeting (AACR) Richard Finn presented the results of the PALOMA-1 study with Ibrance® (palbociclib), an oral inhibitor of cyclin-dependent kinase 4/6 (CDK4/6). Based on the results of this Phase 2 study, palbociclib was recently approved by the United States Drug and Food Administration (U.S. FDA). What is the current level of evidence on palbociclib in approved indications?

Ki67 breast cancer medical writer epotomics

Ki67 in Breast Cancer: an overview

Recent studies have shown new possible applications for Ki67. Huh et al. showed that low Ki67 levels in healthy breast tissue correlated with a lesser lifetime chance of breast cancer. Another study by Arnedos and colleagues concluded that palbociclib was able to invoke a significant Ki67-level drop. After a decade of Ki67-controversies, these results put the marker back in the spotlight.

ASCO 2016 ribociclib & abemaciclib Data - MediPaper Medical Communications

ASCO16 Ribociclib & Abemaciclib Data

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ASCO 2016 Palbociclib Data MediPaper Medical Communications

ASCO16 palbociclib (Ibrance©) Data

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