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Pfizer Inc. today announced the New Drug Application (NDA) for palbociclib
has been accepted for filing and granted Priority Review by the United
States Food and Drug Administration (FDA). This NDA requests FDA approval of
palbociclib, in combination with letrozole, as a first-line treatment for
postmenopausal women with estrogen receptor positive (ER+), human epidermal
growth factor receptor 2 negative (HER2-) advanced breast cancer who have
not received previous systemic treatment for their advanced disease. The
submission is based on the final results of PALOMA-1, a randomized, Phase 2
trial comparing palbociclib plus letrozole versus letrozole alone in this
population of patients.
The FDA's Priority Review status accelerates the review time from 10 months
to a goal of six months from the day of acceptance of filing and is given to
drugs that may offer major advances in treatment or may provide a treatment
where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA)
goal date for a decision by the FDA is April 13, 2015.
Palbociclib received Breakthrough Therapy designation from the FDA in April
2013, for the first-line systemic treatment of women with advanced or
metastatic ER+, HER2- breast cancer.
"If approved as a first-line therapy in combination with letrozole,
palbociclib will be an important new option for the thousands of women in
the U.S. who are living with metastatic breast cancer," said Garry
Nicholson, president, Pfizer Oncology. "We look forward to continuing to
work closely with the FDA through the review process."
Pfizer recently announced the initiation of a multi-center, open-label
expanded access program (EAP) in the United States for palbociclib. Through
the program, palbociclib is available to post-menopausal women with hormone
receptor-positive (HR+), HER2- advanced breast cancer who are eligible for
letrozole therapy and for whom enrolling in other palbociclib clinical
trials is not an option. Healthcare professionals and patients can learn
more about the palbociclib EAP by visiting www.clinicaltrials.gov (trial
number: NCT02142868).
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