Another clinical
trial success story
Ibrance® (palbociclib) trials were halted early by its creator
Pfizer
when it met its primary endpoint—a statistically significant improvement in
progression-free survival in postmenopausal women with HR+, HER2 metastatic
breast cancer. This has been a particularly difficult cancer to treat.
Pfizer announced in an April, 15, 2015 press release:
IBRANCE was approved by the U.S. Food and
Drug Administration (FDA) in February 2015 as a first-line treatment for women
with advanced or metastatic estrogen receptor positive, human epidermal growth
factor receptor 2 negative (ER+/HER2-) breast cancer. IBRANCE® (palbociclib),
in combination with letrozole, is indicated for the treatment of postmenopausal
women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy
for their metastatic disease. This indication is approved under accelerated
approval based on PFS. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in a confirmatory trial.
The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. IBRANCE is not
approved for the use being investigated in PALOMA-3 or for any indication in
any market outside the U.S.
The trials were conducted in more than 150 global sites. Although
the FDA has approved Ibrance®, the Phase III studies are ongoing. The combination
of Ibrance®
plus letrozole extended progression-free survival by about 50% (from 10.2
months with letrozole alone to 20.2 months with the combination) in the Phase
II part of the study.
If you or somebody you know might benefit from this drug,
talk to your doctors.
The American
Cancer Society (ACS) estimates that more than 230,000 American women will
be diagnosed the breast cancer and more than 39,000 women will die from breast
cancer this year. This new drug is expected to prolong many lives.
This drug is one of the new generation of highly effective
and very expensive drugs. The projected cost of Ibrance® will be $9,850 a month. This is not out of line with
other recently approved cancer treatment drugs.
For more information on clinical trials, what they are,
where they are, and if you might qualify to participate, go to the National Institutes of Health clinical
trials site.
Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
