Download Ibrance

yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts
no text concepts found
February 3rd 2015 FDA approved the release of Ibrance
Used for the treatment of: Postmenopausal women with
advanced breast cancer.
Dosage: One oral dose daily for 21 days.
Marketing Information from Manufacturer: “The addition of
palbociclib to letrozole provides a novel treatment option to women
diagnosed with metastatic breast cancer,” said Richard Pazdur, M.D.,
director of the Office of Hematology and Oncology Products in the
FDA’s Center for Drug Evaluation and Research. Steven I. Sherman,
MD, associate vice-provost for Clinical Research, and professor and
chair, Endocrine Neoplasia and Hormonal Disorders, MD Anderson
said “In our study, we not only saw a dramatic improvement in
progression-free survival, there was also a 65 percent response rate
– almost unprecedented results for thyroid cancer patients with such
advanced disease. We also found a strongly suggestive trend in how
long patients lived, and a small number of patients had a complete
response. While we couldn’t identify tumor mutations that might
predict response, this represents a very exciting area of study going
forward in hopes of possibly offering cure to a greater number of
Ib r an c e (EYE-brans)
A vo id gr ap e fr u it an d
gr ap efr u it p r od u ct s
d u r in g tr e atm en t w it h
IB R ANC E . Gr ap e fr u it
m ay in cr ea se th e
am ou n t o f IB R AN C E in
you r b lood .
Gen er ic N am e
p alb oc ic lib
Benefits and Concerns of the Drug: : The FDA granted Ibrance
breakthrough therapy designation because the sponsor demonstrated
through preliminary clinical evidence that the drug may offer a
substantial improvement over available therapies. It also received a
priority review, which provides for an expedited review of drugs
intended to provide a significant improvement in safety or
effectiveness in the treatment of a serious condition or meet an unmet
medical need.
Special points of interest
Coverage Recommendations: These recommendations are
available to IPC/EvergreenRx clients from their Account Manager or
Clinical Pharmacist.
Please contact us with any questions or comments
T 636.614.1344
A Brown & Brown company