EU, US Approvals for Faslodex Combinations

Excerpt:

“AstraZeneca’s Faslodex has been cleared on both sides of the Atlantic for use in combination with a CDK4/6 inhibitor.

“In the EU, the drug’s use has been approved for use alongside the CDK4/6 inhibitor palbociclib to treat a certain form of breast cancer, in the US it can be prescribed in combination with the CDK4/6 inhibitor abemaciclib.

“Both the European Commission and US Food and Drug Administration have approved the combination for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.”

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FDA Approves Verzenio for Hormone Receptor-Positive, HER-2-Negative Breast Cancer

Excerpt:

“The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.”

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Fulvestrant Gains New Breast Cancer Indication

Excerpt:

“The FDA expanded the indications for fulvestrant (Faslodex) to include use as first-line monotherapy in postmenopausal women with estrogen receptor-positive, HER-2 negative breast cancer, drugmaker AstraZeneca said Monday.

“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”

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Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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Adding Everolimus to Fulvestrant Improved Outcomes for Postmenopausal Patients With HR-positive Breast Cancer

Excerpt:

“Progression-free survival was more than doubled for patients with metastatic hormone receptor (HR)-positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data from the PrECOG 0102 phase II clinical trial presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6–10.

” ‘Endocrine therapy, often with an aromatase inhibitor, is the standard of care for most patients with HR-positive advanced breast cancer,’ said Noah S. Kornblum, MD, assistant professor of medicine at Albert Einstein College of Medicine and attending physician, medicine at Montefiore Einstein Center for Cancer Care. ‘However, over time, resistance to aromatase inhibitors develops and treating patients with aromatase inhibitor–resistant disease remains a challenge.’ ”

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Fulvestrant Bests Anastrozole in Phase III Breast Cancer Study

Excerpt:

“First-line treatment with fulvestrant (Faslodex) led to significantly better progression-free survival (PFS) compared with anastrozole for patients with hormone receptor (HR)-positive advanced breast cancer, according to findings from the phase III FALCON trial reported at the 2016 ESMO Congress.

“Confirming results of an earlier phase II study, the FALCON trial yielded a median PFS of 16.6 months with fulvestrant versus 13.8 months with anastrozole. Moreover, a consistent advantage favoring fulvestrant emerged from a subgroup analysis. The overall advantage appeared to be driven by a substantial difference in PFS among patients without visceral metastases treated with fulvestrant.”

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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.”


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.”