Pfizer 2014 Annual Report Download - page 50

PFIZER ANNUAL REVIEW 2014 www.pzer.com/annual 50
ANNUAL REVIEW 2014
Trumenba® Approved and Available to
Prevent Meningitis B
Trumenba (meningococcal group B vaccine) is the rst
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 nal 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 rst-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 Pzer in ER+/HER2- breast cancer across
stages and treatment settings, and several Phase 3 studies
are underway globally. In addition, Pzer has initiated external
collaborations to evaluate Ibrance in other tumor types.
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