Another clinical trial success story
Ibrance® (palbociclib) trials were halted early by its creator Pfizerwhen 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