FDA Expands Palbociclib Approval for Breast Cancer

“The Food and Drug Administration (FDA) has granted an expanded indication for the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug is now approved for use in combination with fulvestrant in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed following endocrine therapy.

“Palbociclib was initially approved in February 2015 for the treatment of estrogen receptor–positive, HER2-negative metastatic breast cancer, in women who had not yet received endocrine therapy. The new approval was granted under the FDA’s breakthrough therapy designation.

“The additional indication for palbociclib is based on results from the PALOMA-3 trial, which was stopped early in April 2015 after an interim analysis showed benefit in combination with fulvestrant when compared to fulvestrant and placebo.”


Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Pfizer’s supplemental New Drug Application (sNDA) for IBRANCE was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.”


Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“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.”


FDA Grants Priority Review to Ibrance for New Indication in Advanced Breast Cancer

“The FDA granted priority review to a supplemental new drug application for the breast cancer medication palbociclib.

“Palbociclib (Ibrance, Pfizer) — an oral agent that inhibits cyclin-dependent kinases (CDK) 4 and 6 — already is approved for use in combination with letrozole for treatment of postmenopausal women with ER-positive, HER-2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.

“The supplemental application requests that the approval be expanded to allow for use of palbociclib in combination with fulvestrant in women with hormone receptor-positive, HER-2–negative metastatic breast cancer that progressed after endocrine therapy. The application requests approval in this setting regardless of patients’ menopausal status or receipt of prior treatment for metastatic disease.”


Palbociclib's Role in Endocrine-Resistant Breast Cancer

“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.


Top Takeaways from ASCO: Breast Cancer

“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.”


ASCO Highlight: Another Treatment Option for ER-Positive Breast Cancer


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…


Video: Dr. Kari Wisinski on Palbociclib for Metastatic Breast Cancer

“Kari Wisinski, MD, medical oncologist with University Of Wisconsin Health and the University of Wisconsin Carbone Cancer Center, discusses the use of palbociclib for patients with ER-positive and HER2-negative breast cancer.

“Currently there is not a specific patient population that has been identified as ideal for palbociclib, says Wisinski.

“The PALOMA-3 trial demonstrated that palbociclib plus fulvestrant compared with fulvestrant plus placebo improved progression-free survival (PFS) in women with ER-positive and HER2-negative metastatic breast cancer following disease progression. Based on these results, the drug gained accelerated approval in February 2015.

“The PFS data is impressive, says Wisinski, and the swift approval of the drug has benefited patients who need to delay chemotherapy while maintaining PFS.”


Pfizer's Ibrance Drug Slows Progression of Breast Cancer

“A Phase III trial of Pfizer Inc’s Ibrance showed that, in combination with hormone therapy, the drug more than doubled the duration of disease control for women with the most common type of breast cancer.

“At the time of an interim analysis, patients given Ibrance and AstraZeneca Plc’s Faslodex (fulvestrant), a widely used treatment to block estrogen, lived an average of 9.2 months before their cancer worsened. This compared with 3.8 months for patients treated with Faslodex and a placebo.

“The trial, presented in Chicago at a meeting of the American Society of Clinical Oncology, enrolled 521 patients whose breast cancer was classified as estrogen-receptor positive, human epidermal growth factor receptor 2-negative. This category accounts for about 75 percent of all breast cancers.

“Ibrance, or palbociclib, was given conditional approval by the U.S. Food and Drug Administration in February for such patients, but only those who had not previously been treated for advanced breast cancer.”