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Palbociclib

Generic Name
Palbociclib
Brand Names
Ibrance
Drug Type
Small Molecule
Chemical Formula
C24H29N7O2
CAS Number
571190-30-2
Unique Ingredient Identifier
G9ZF61LE7G

Overview

Palbociclib is a piperazine pyridopyrimidine that acts in the cell cycle machinery. It is a second generation cyclin-dependent kinase inhibitor selected from a group of pyridopyrimidine compounds due to its favorable physical and pharmaceutical properties. Palbociclib was developed by Pfizer Inc after the discovery that identified the cyclin-dependent kinases as key regulators of cell growth. It was originally FDA approved on March 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer and its indications were updated in April 2019 to include male patients based on findings from postmarketing reports and electronic health records demonstrating safety and clinical efficacy.

Background

Palbociclib is a piperazine pyridopyrimidine that acts in the cell cycle machinery. It is a second generation cyclin-dependent kinase inhibitor selected from a group of pyridopyrimidine compounds due to its favorable physical and pharmaceutical properties. Palbociclib was developed by Pfizer Inc after the discovery that identified the cyclin-dependent kinases as key regulators of cell growth. It was originally FDA approved on March 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer and its indications were updated in April 2019 to include male patients based on findings from postmarketing reports and electronic health records demonstrating safety and clinical efficacy.

Indication

Palbociclib is indicated in combination with letrozole as initial endocrine-based therapy for the treatment of human epidermal growth factor receptor type 2 (HER2)-negative and hormone receptor(HR)-positive tumors in adult patients with advanced/metastatic breast cancer. It is as well approved in combination with fulvestrant in patients with disease progression with prior endocrine therapy. In the official labeling, the use of palbociclib should be accompanied with either an aromatase inhibition, no restricted to letrozole, as initial endocrine-based therapy in postmenopausal women or in man. The breast cancer starts as a group of cancer cells that grow into and destroy the nearby breast tissue. This growth can spread into other parts of the body which is called metastasis. According to the location of the cancer cells, it can be categorized in ductal carcinoma and lobular carcinoma. However, other types of breast cancer include inflammatory breast cancer, Paget disease of the breast, triple negative breast cancer non-Hodgkin lymphoma and soft tissue sarcoma. In males, breast cancer is usually treated as the cases of postmenopausal women and almost all the cases are ductal carcinoma.

Associated Conditions

  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Refractory, advanced Breast cancer
  • Refractory, metastatic Breast cancer

FDA Approved Products

Ibrance
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:125 mg in 1 1
Approved: 2019/09/15
NDC:63539-189
Ibrance
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:75 mg in 1 1
Approved: 2023/09/08
NDC:0069-0284
Ibrance
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:75 mg in 1 1
Approved: 2019/11/15
NDC:63539-284
Ibrance
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:100 mg in 1 1
Approved: 2019/11/15
NDC:63539-486
Ibrance
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:75 mg in 1 1
Approved: 2019/09/15
NDC:63539-187

Singapore Approved Products

IBRANCE CAPSULE 125mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:CAPSULE
Strength:125.000mg
Online:Yes
Approved: 2016/07/21
Approval:SIN15050P
PALBOCICLIB SANDOZ CAPSULE 75MG
Manufacturer:Aizant Drug Research Solutions Pvt Ltd.
Form:CAPSULE
Strength:75.00 mg
Online:Yes
Approved: 2024/05/09
Approval:SIN17005P
PALBOCICLIB SANDOZ CAPSULE 125MG
Manufacturer:Aizant Drug Research Solutions Pvt Ltd.
Form:CAPSULE
Strength:125.00 mg
Online:Yes
Approved: 2024/05/09
Approval:SIN17007P
IBRANCE CAPSULE 100mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:CAPSULE
Strength:100.000mg
Online:Yes
Approved: 2016/07/21
Approval:SIN15049P
IBRANCE CAPSULE 75mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:CAPSULE
Strength:75.000mg
Online:Yes
Approved: 2016/07/21
Approval:SIN15048P

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