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For Advanced Breast Cancer
NEW YORK, NY -- November 9, 2000 -- New clinical findings from two studies presented for the first time in the US show FemaraŽ (letrozole tablets) to be significantly more effective than tamoxifen (the current gold standard) in treating postmenopausal women with advanced breast cancer in both the first-line and pre-operative settings.
The trial results were presented at the Chemotherapy Foundation Symposium in New York.
In the largest study ever evaluating hormone therapy in advanced breast cancer, the number of women in whom the breast cancer had not progressed after a year of treatment was nearly 50 percent greater in patients taking Femara than in those taking tamoxifen. Femara, an aromatase inhibitor, is a once-a-day oral treatment currently indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. The FDA approved Femara for this indication 1997.
"Femara is the first breast cancer treatment to demonstrate consistent superiority over tamoxifen in multiple efficacy endpoints," said Matthew Ellis, MD, Ph.D., FRCP, Clinical Director, Duke Breast Cancer Program, Duke University Medical Center. "These study results will lead us to consider changing practice guidelines for advanced breast cancer and could pave the way for Femara as first-line therapy."
In this study of more than 900 women comparing the efficacy of Femara and tamoxifen as first-line treatment for advanced breast cancer, it was shown that Femara delays progression of advanced breast cancer for longer than tamoxifen (41 weeks vs. 26 weeks). Results also indicate significant differences between Femara and tamoxifen with respect to overall tumor response rates (30 percent vs. 20 percent), duration of clinical benefit (49 percent vs. 38 percent) and time to treatment failure (40 weeks vs. 25 weeks).
The women enrolled in this phase III randomized, double-blind multi-center trial were postmenopausal with either locally advanced (stage IIIB) disease, metastatic breast cancer or had recurrences not amenable to treatment with surgery or radiotherapy.
In this phase III randomized controlled trial of 324 postmenopausal women, patients with large localized or locally advanced breast cancer tumors were given Femara or tamoxifen as pre-operative treatment to reduce tumor size before surgery. Clinical responses after four months of preoperative therapy were significantly better for Femara than for tamoxifen (55 percent versus 36 percent) and, as a result, more women on Femara underwent breast-conserving surgery compared to tamoxifen (45 percent versus 35 percent). After adjustment for tumor size, nodal involvement and age, the odds of undergoing breast-conserving surgery were increased by more than 70 percent for Femara compared tamoxifen. In both studies, Femara and tamoxifen were equally well tolerated.
"Novartis Oncology is very encouraged by these data, which demonstrate that Femara can offer physicians and patients a drug that can make a significant impact," said David Parkinson, Vice President, Global Oncology Clinical Research at Novartis Oncology. "Femara could ultimately represent a major advance in the treatment paradigm for women with metastatic disease."
Femara is currently available in more than 75 countries worldwide. A supplemental new drug application (sNDA) was filed for Femara with the FDA for use in first-line therapy, which is currently under review. This filing has been designated for priority review. The FDA's Oncologic Drugs Advisory Committee (ODAC) will meet on December 13, 2000 to discuss the application for the first-line indication. Regulatory submissions for this indication have also been filed globally.
Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Most commonly reported adverse effects with Femara in the second-line trials have been musculoskeletal pain (21 percent), nausea (13 percent), headache (9 percent), arthralgia or joint pain (8 percent), fatigue (8 percent), vomiting (7 percent), and dyspnea or labored breathing (7 percent).
Thanks to Basskiller @ WCBB
NEW YORK, NY -- November 9, 2000 -- New clinical findings from two studies presented for the first time in the US show FemaraŽ (letrozole tablets) to be significantly more effective than tamoxifen (the current gold standard) in treating postmenopausal women with advanced breast cancer in both the first-line and pre-operative settings.
The trial results were presented at the Chemotherapy Foundation Symposium in New York.
In the largest study ever evaluating hormone therapy in advanced breast cancer, the number of women in whom the breast cancer had not progressed after a year of treatment was nearly 50 percent greater in patients taking Femara than in those taking tamoxifen. Femara, an aromatase inhibitor, is a once-a-day oral treatment currently indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. The FDA approved Femara for this indication 1997.
"Femara is the first breast cancer treatment to demonstrate consistent superiority over tamoxifen in multiple efficacy endpoints," said Matthew Ellis, MD, Ph.D., FRCP, Clinical Director, Duke Breast Cancer Program, Duke University Medical Center. "These study results will lead us to consider changing practice guidelines for advanced breast cancer and could pave the way for Femara as first-line therapy."
In this study of more than 900 women comparing the efficacy of Femara and tamoxifen as first-line treatment for advanced breast cancer, it was shown that Femara delays progression of advanced breast cancer for longer than tamoxifen (41 weeks vs. 26 weeks). Results also indicate significant differences between Femara and tamoxifen with respect to overall tumor response rates (30 percent vs. 20 percent), duration of clinical benefit (49 percent vs. 38 percent) and time to treatment failure (40 weeks vs. 25 weeks).
The women enrolled in this phase III randomized, double-blind multi-center trial were postmenopausal with either locally advanced (stage IIIB) disease, metastatic breast cancer or had recurrences not amenable to treatment with surgery or radiotherapy.
In this phase III randomized controlled trial of 324 postmenopausal women, patients with large localized or locally advanced breast cancer tumors were given Femara or tamoxifen as pre-operative treatment to reduce tumor size before surgery. Clinical responses after four months of preoperative therapy were significantly better for Femara than for tamoxifen (55 percent versus 36 percent) and, as a result, more women on Femara underwent breast-conserving surgery compared to tamoxifen (45 percent versus 35 percent). After adjustment for tumor size, nodal involvement and age, the odds of undergoing breast-conserving surgery were increased by more than 70 percent for Femara compared tamoxifen. In both studies, Femara and tamoxifen were equally well tolerated.
"Novartis Oncology is very encouraged by these data, which demonstrate that Femara can offer physicians and patients a drug that can make a significant impact," said David Parkinson, Vice President, Global Oncology Clinical Research at Novartis Oncology. "Femara could ultimately represent a major advance in the treatment paradigm for women with metastatic disease."
Femara is currently available in more than 75 countries worldwide. A supplemental new drug application (sNDA) was filed for Femara with the FDA for use in first-line therapy, which is currently under review. This filing has been designated for priority review. The FDA's Oncologic Drugs Advisory Committee (ODAC) will meet on December 13, 2000 to discuss the application for the first-line indication. Regulatory submissions for this indication have also been filed globally.
Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Most commonly reported adverse effects with Femara in the second-line trials have been musculoskeletal pain (21 percent), nausea (13 percent), headache (9 percent), arthralgia or joint pain (8 percent), fatigue (8 percent), vomiting (7 percent), and dyspnea or labored breathing (7 percent).
Thanks to Basskiller @ WCBB