(RxWiki News) The FDA has given Pfizer’s breast cancer compound a “Breakthrough Therapy” designation. This will fast-track the medication’s development and review because this compound may offer important new treatments advantages.
The investigational compound - palbociclib (PD-0332991) – is currently being evaluated in an ongoing trial as a potential first-line treatment for estrogen receptor-positive (ER+) breast cancer in postmenopausal women with locally advanced or metastatic (has spread) breast cancer.
The study, a randomized, multi-center, double-blind Phase lll study (known as Study 1008), is currently enrolling participants.
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Preliminary findings reported at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium showed that women treated with a combination of letrozole (brand name Femara) and palbociclib significantly increased the time before the disease progressed (progression-free survival, or PFS).
Women treated with the combination had a PFS of 26.1 months compared to 7.5 months with letrozole alone.
The compound – which is given orally in pill form – is also being evaluated to treat other cancers, including liver, ovarian, lung, brain, melanoma and others.
PD-0332991 is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, which means it interrupts the cancer cell's ability to grow and replicate.
Click on the clinicaltrials.gov link below for more information on these trials.