Specialty Pharma Journal Specialty, Precision & Technology
NEW YORK–(BUSINESS WIRE)–Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine …
Tag Archives: palbociclib
June, 2018
December, 2017
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7 December
Pfizer Announces Updated Progression-Free Survival Results from Late-Stage Trial Reinforcing the Benefit of Ibrance Plus Letrozole in Breast Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of IBRANCE® (palbociclib) combined with letrozole. The data, which will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 8 [abstract #P5-21-03], demonstrate that the …
April, 2017
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3 April
Pfizer’s Ibrance Receives FDA Regular Approval and Expanded Indication for Metastatic Breast Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, IBRANCE® (palbociclib), based on the results from the confirmatory Phase 3 trial PALOMA-2. The FDA action converts …
March, 2016
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3 March
FDA Approves New Indication for AstraZeneca’s Faslodex
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) …
February, 2016
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22 February
FDA Expands Approval of Pfizer’s Ibrance in Metastatic Breast Cancer
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) …
January, 2016
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4 January
Experts Find Breast Cancer Drug May be Effective in Other Cancer Types
PHILADELPHIA—Palbociclib, a new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy, also has potential to combat other types of cancer, according to a literature review and additional original research conducted by experts at the Abramson Cancer Center (ACC) in the University …
October, 2015
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21 October
Novartis Expands its Immuno-Oncology Pipeline through Acquisitions and Licensing Agreements
Basel, October 21, 2015 – Novartis announced today that it is broadening its portfolio of cancer immunotherapies with the acquisition of Admune Therapeutics and licensing agreements with Palobiofarma and XOMA Corporation. With four candidates currently in clinical trials and five more agents expected to enter the clinic by the end …
February, 2015
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4 February
Pfizer’s Breast Cancer Drug Receives Accelerated Approval from the FDA
Federal health regulators have provided an early approval to Pfizer Inc.’s Breakthrough breast cancer drug palbociclib. The company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Ibrance (palbociclib) in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth …
January, 2015
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8 January
Pfizer Provides Update on its Breast Cancer Candidate
Today, Pfizer Inc. announced that it is in discussion with the US Food and Drug Administration (FDA), regarding its potential blockbuster breast cancer drug palbociclib. According to the company, it expects to get a final decision from the agency by April 13. Pfizer said that the FDA is not requiring …