Novartis To File Femara Early Adjuvant NDA In Second Quarter
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will release topline data from a pivotal study of letrozole in early adjuvant treatment of breast cancer Jan. 26. Femara sales grew 62% in 2004 to $386 mil.; Novartis expects the aromatase inhibitor will reach $1 bil. in sales by 2008.
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Novartis Submits Femara For Early Adjuvant Treatment Of Breast Cancer
Femara would be first breast cancer drug with adjuvant and extended adjuvant approvals, Novartis says. Supplemental NDA is based on a reduction of the risk of recurrence in the BIG 1-98 trial; the 8,000-patient study is continuing to determine if monotherapy or sequential therapy with tamoxifen is more effective.
Novartis Submits Femara For Early Adjuvant Treatment Of Breast Cancer
Femara would be first breast cancer drug with adjuvant and extended adjuvant approvals, Novartis says. Supplemental NDA is based on a reduction of the risk of recurrence in the BIG 1-98 trial; the 8,000-patient study is continuing to determine if monotherapy or sequential therapy with tamoxifen is more effective.
Novartis Femara Adds Extended Adjuvant Breast Cancer Treatment Indication
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