Pfizer Inc. today announced the launch of a competitive, peer-reviewed grants program to support clinical research projects investigating IBRANCE® (palbociclib) in advanced breast cancer. The multi-year program, which will award a total of up to $3 million in grants to investigators in the United States, is an extension of Pfizer's Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) initiative. It is the first ASPIRE program to focus on breast cancer research.
IBRANCE received accelerated approval by the U.S. Food and Drug Administration in February 2015 for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
"We believe the ASPIRE Breast Cancer Research Awards will contribute important information to our body of knowledge about the role IBRANCE plays in the treatment and clinical management of advanced breast cancer, and will complement the robust clinical development program we have ongoing," said Dr. Julia Perkins Smith, senior medical director, U.S. Breast Cancer Lead, Pfizer Oncology. "Through these awards, we also look forward to supporting the mission of the ASPIRE program to further academic research and nurture the career development of emerging investigators in a disease area of high unmet medical need."
"This is an exciting opportunity to gain a better understanding of the efficacy and tolerability of CDK inhibition in ER+ breast cancer," said Dr. Ruth O’Regan, head of hematology and oncology in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health.
Grantees will be selected through a competitive application process overseen by an independent review panel of breast cancer experts.
The review panel encourages investigators (with a special interest for emerging researchers at Assistant Professor level or equivalent) to submit applications for innovative research in several areas. Highlights of the research of interest include:
- Improving the medical knowledge of palbociclib in the treatment of advanced breast cancer
- Optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes
For more information about the ASPIRE Breast Cancer Research Awards and specifics regarding eligible areas of research, please visit www.aspireresearch.org. The application submission period ends September 8, 2015, and successful awardees will be notified in October. Pfizer anticipates providing up to six awards to investigators in the United States.
About IBRANCE®
IBRANCE is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.(1) CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression.(2,3) IBRANCE is indicated in the U.S. for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The effectiveness of IBRANCE in these patients is based on a study that measured progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.
1. IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2015.
2. Weinberg RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.
3. Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.