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Ribociclib: First Global Approval.

Abstract Ribociclib is an oral, small-molecule inhibitor of cyclin-dependent kinase (CDK) 4 and 6 that is under development by Novartis for the treatment of cancer. CDKs play an important role in cell cycle progression and cellular proliferation, and inhibition of these kinases with ribociclib results in G1 phase cell-cycle arrest. Ribociclib, in combination with an aromatase inhibitor, was recently approved in the USA for the first-line treatment of advanced breast cancer and has been submitted for approval in the EU for this indication. Ribociclib is undergoing further phase III investigations in breast cancer and is being evaluated in phase I or II trials for various solid tumour types and haematological malignancies. This article summarizes the milestones in the development of ribociclib leading to this first global approval for use as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title drugs
Publication Year Start




PMID- 28417244
OWN - NLM
STAT- MEDLINE
DA  - 20170418
DCOM- 20170515
LR  - 20170515
IS  - 1179-1950 (Electronic)
IS  - 0012-6667 (Linking)
VI  - 77
IP  - 7
DP  - 2017 May
TI  - Ribociclib: First Global Approval.
PG  - 799-807
LID - 10.1007/s40265-017-0742-0 [doi]
AB  - Ribociclib is an oral, small-molecule inhibitor of cyclin-dependent kinase (CDK) 
      4 and 6 that is under development by Novartis for the treatment of cancer. CDKs
      play an important role in cell cycle progression and cellular proliferation, and 
      inhibition of these kinases with ribociclib results in G1 phase cell-cycle
      arrest. Ribociclib, in combination with an aromatase inhibitor, was recently
      approved in the USA for the first-line treatment of advanced breast cancer and
      has been submitted for approval in the EU for this indication. Ribociclib is
      undergoing further phase III investigations in breast cancer and is being
      evaluated in phase I or II trials for various solid tumour types and
      haematological malignancies. This article summarizes the milestones in the
      development of ribociclib leading to this first global approval for use as
      initial endocrine-based therapy for the treatment of postmenopausal women with
      hormone receptor-positive, human epidermal growth factor receptor 2-negative
      advanced or metastatic breast cancer.
FAU - Syed, Yahiya Y
AU  - Syed YY
AD  - Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
      [email protected]
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Drugs
JT  - Drugs
JID - 7600076
RN  - 0 (Aminopyridines)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Aromatase Inhibitors)
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (Purines)
RN  - EC 2.7.11.22 (CDK4 protein, human)
RN  - EC 2.7.11.22 (CDK6 protein, human)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 4)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 6)
RN  - TK8ERE8P56 (ribociclib)
SB  - IM
MH  - Administration, Oral
MH  - Aminopyridines/*administration & dosage/adverse
      effects/*pharmacokinetics/pharmacology
MH  - Antineoplastic Agents/*administration & dosage/adverse
      effects/pharmacokinetics/pharmacology
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Aromatase Inhibitors/pharmacology
MH  - Breast Neoplasms/*drug therapy
MH  - Clinical Trials as Topic
MH  - Cyclin-Dependent Kinase 4/antagonists & inhibitors
MH  - Cyclin-Dependent Kinase 6/antagonists & inhibitors
MH  - Drug Approval
MH  - Enzyme Inhibitors/*administration & dosage/adverse
      effects/pharmacokinetics/pharmacology
MH  - Female
MH  - Humans
MH  - Purines/*administration & dosage/adverse effects/*pharmacokinetics/pharmacology
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2017/04/19 06:00
MHDA- 2017/05/16 06:00
CRDT- 2017/04/19 06:00
AID - 10.1007/s40265-017-0742-0 [doi]
AID - 10.1007/s40265-017-0742-0 [pii]
PST - ppublish
SO  - Drugs. 2017 May;77(7):799-807. doi: 10.1007/s40265-017-0742-0.

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