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The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
