“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”
“Among women with locally advanced or metastatic hormone receptor-positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant, according to data from the phase III BELLE-2 trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.
“ ‘BELLE-2 is a randomized, phase III clinical trial designed to assess the efficacy of the investigational PI3K inhibitor buparlisib in combination with fulvestrant in breast cancer patients whose tumors no longer respond to aromatase inhibitors,’ said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.”
“Results of a multicenter phase 1 clinical trial presented today at the 2015 San Antonio Breast Cancer Symposium show that the anti-androgen agent enzalutamide is active and well-tolerated alone and with fulvestrant in patients with advanced breast cancer. The study takes another important step toward larger clinical trials targeting androgen receptors in breast cancer.
” ‘We’ve known for years that prostate cancer is driven by androgens and now it’s increasingly clear that androgens and androgen receptors can influence many breast cancers as well. AR is actually even more prevalent in breast cancer than estrogen or progesterone receptors. Targeting androgen receptors in breast cancer gives us a new way to attack the disease,’ says Jennifer Richer, PhD, investigator at the University of Colorado Cancer Center. Results represent collaboration with CU Cancer Center clinical collaborator Anthony Elias, MD, Memorial Sloan Kettering, Medivation, Inc. and Astellas Pharma Global Development.”
“Palbociclib (Ibrance, Pfizer), the first CDK4/6 inhibitor to be approved for the treatment of breast cancer, has been welcomed by experts for its role in improving outcomes in patients with endocrine-resistant breast cancer.
“The drug should a significant improvement in progression-free survival (PFS) when it was added to fulvestrant (Faslodex, AstraZeneca) in the phase 3 PALOMA 3 trial, as reported recently by Medscape Medical News. The addition of palbociclib to fulvestrant increased median PFS to 9.2 months in patients with estrogen receptor (ER)–positive/HER2-negative endocrine-resistant breast cancer compared with 3.8 months in the placebo-fulvestrant group (P < .001).
“The overall survival data are still immature.
“The full results have now been published in print in the July 16 issue of the New England Journal of Medicine.
“Physicians managing patients with various breast cancer diagnoses left ASCO 2015 with new data to consider when making decisions every day – some practice-changing, others potentially so.
“Key opinion leaders offer their views on positive results from trials investigating an adjunct endocrine therapy, an aromatase inhibitor as an option to tamoxifen, a novel chemotherapy and bisphosphonates.
“Nicholas C. Turner, MD, PhD, a consultant medical oncologist at the Royal Marsden and a team leader at the Institute of Cancer Research in London, and colleagues assessed the safety and efficacy of combining palbociclib (Ibrance, Pfizer), an oral agent that blocks cyclin dependent kinases 4 and 6, with fulvestrant (Faslodex, AstraZeneca) in women with hormone receptor-positive, HER-2–negative advanced breast cancer who had progressed on prior endocrine therapy.
“ ‘The palbociclib data with fulvestrant builds on this whole concept of partnering endocrine therapy with another agent,’ William J. Gradishar, MD, FACP, professor of medicine in the division of hematology and medical oncology, Northwestern University Feinberg School of Medicine, and breast cancer section editor for HemOnc Today, told Healio.com.”
Earlier this year, a new treatment option was added to the arsenal for ER-positive breast cancer in postmenopausal women when the U.S. Food and Drug Administration (FDA) approved the combination of letrozole (Femara) and palbociclib (Ibrance). Continue reading…