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A STORY HALF TOLD
Trumenba® Approved and Available to Prevent Meningitis B
Trumenba (meningococcal group B vaccine) is the first FDA-approved vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Trumenba was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.
The unmet medical need was great. This disease is characterized by high fatality rates and rapid onset, often within 24 hours. For individuals 11–24 years of age, approximately 30 percent of meningococcal disease is serogroup B in the U.S., and 10 percent of these cases result in death.1 As many as 60 percent of adolescent survivors of meningococcal disease, 15–19 years of age, suffer from permanent life-altering consequences such as hearing loss, neurologic damage, or loss of a limb.2 Between the years 2010 and 2012, the estimated average annual serogroup B cases in 11- through 24-year-olds was 48–56 cases in the U.S.3
1 Centers for Disease Control and Prevention. Prevention and Control of Meningococcal Disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013 March 22; 62(RR02); 1–28. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1.htm. Last updated March 22, 2013. Accessed November 17, 2014.
2 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal Disease in Adolescence: prospective, matched-cohort study. Pediatrics. 2009; 123: e502–e509.
3 MacNeil J. Epidemiology of Serogroup B Meningococcal Disease, United States. Advisory Committee on Immunization Practices, October 30, 2014. http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-10/mening-02-MacNeil.pdf.
Ibrance® (Palbociclib) Approved by the U.S. FDA
On February 3, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Ibrance® (palbociclib), in combination with letrozole, for the treatment of post-menopausal 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. Ibrance, an oral kinase inhibitor, was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.
The FDA approval of Ibrance is based on the final results of the Phase 2 PALOMA-1 trial. The study demonstrated that the combination of Ibrance and letrozole prolonged progression-free survival compared with letrozole alone, a standard of care, in post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer. Detailed results from the PALOMA-1 trial have been published in The Lancet Oncology.
Prior to the FDA approval of Ibrance, patients with ER+/HER2- advanced breast cancer had not seen a first-line treatment advance in more than 10 years. This is the most common type of advanced breast cancer, affecting an estimated 60 percent of patients.
Ibrance selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6, key regulators of the cell cycle, to regain cell cycle control and block tumor cell proliferation. Ibrance is being developed by Pfizer in ER+/HER2- breast cancer across stages and treatment settings, and several Phase 3 studies are underway globally. In addition, Pfizer has initiated external collaborations to evaluate Ibrance in other tumor types.
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