Palbociclib Efficacious in Metastatic Breast Cancer

Excerpt:

“Palbociclib can help slow the progression of advanced breast cancer, according to a study published in the Nov. 17 issue of the New England Journal of Medicine.

“Richard Finn, M.D., an assistant professor of medicine at the University of California, Los Angeles, and colleagues tested palbociclib-letrozole as a first-line treatment for estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative . They randomly assigned 666 women to receive the or letrozole alone, and followed them for up to three years.

“At that point, the researchers found that 43.7 percent of women in the palbociclib group had either died or seen their cancer progress. That compared with 61.7 percent of women on letrozole alone. Women on the drug combination typically remained progression-free for 24.8 months, versus 14.5 months for women on letrozole. One of the most common side effects—seen in two-thirds of in this study—was neutropenia.”

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Results of Two Practice-Changing Breast Cancer Trials Upheld

Excerpt:

“Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings.

“The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food and Drug Administration (FDA) approval of the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug was approved in combination with letrozole for the first-line treatment of metastatic disease.

“ ‘These data represent the longest front-line improvement in median progression-free survival seen to date in women with advanced estrogen receptor (ER)-positive breast cancer,’ said Dennis Slamon, MD, Director of Clinical/Translational Research and Professor of Medicine at the University of California, Los Angeles, and Director of the Revlon/UCLA Women’s Cancer Research Program.”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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Palbociclib Showed Antiproliferative Activity in Early-stage Breast Cancer

Excerpt:

“The molecularly targeted therapeutic palbociclib (Ibrance), which is used to treat advanced breast cancer, was effective in slowing the multiplication of cancer cells in patients diagnosed with early-stage breast cancer who received no prior therapy, according to data from a phase II clinical trial presented here at the AACR Annual Meeting 2016, April 16-20.

” ‘The use of targeted therapies has been increasing in the last few years. It is crucial to determine that these drugs do hold activity against tumor cells,’ said the study’s lead author, Monica Arnedos, MD, an assistant professor at Gustave Roussy Cancer Campus in Villejuif, France. ‘In the case of palbociclib, no predictive biomarkers have been identified to date, and there are still no data about its potential efficacy in the early setting.’ ”

“Palbociclib, an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for use in combination with the anti-estrogen therapeutic letrozole for treating postmenopausal women with a specific subtype of breast cancer: estrogen receptor-positive, HER2-negative, metastatic breast cancer.”

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FDA Approves New Indication for FASLODEX® (Fulvestrant)

“AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

“Estrogen receptor (ER) positive breast cancer is the most common subtype of breast cancer and one of the key drivers of disease progression for this subtype is through the ER. Laboratory studies show that FASLODEX directly targets the ER by blocking and degrading the ER, helping to inhibit tumor growth.”


Drug Combination Slows Breast Cancer Spread

“A combination of two drugs delays progression of advanced, aggressive breast cancer by an average of nine months – working in all subsets of the most common type of breast cancer.

“The combination – of a first-in-class targeted drug called palbociclib, and the hormone drug fulvestrant – slowed cancer growth in around two-thirds of women with advanced forms of the most common type of breast cancer.

“The combination allowed many women with metastatic hormone-receptor-positive, HER2-negative cancer to delay the start of chemotherapy, which is the traditional treatment option in these patients once hormone drugs have stopped working.”


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.”