Advisory panel OKs Evista to reduce breast cancer risk

Share this article:

An FDA advisory panel voted to back Eli Lilly's request to tell patients its osteoporosis treatment Evista (raloxifene) also helps reduce the risk of breast cancer, despite concerns over the drug's cardiovascular side effects.

The panel of outside experts voted 10-4 in favor of allowing Lilly to re-label Evista as cutting the “risk of invasive breast cancer in women at high risk for breast cancer.”

The panel also voted 8-6 to state Evista cuts breast cancer risk “in postmenopausal women with osteoporosis.”
The votes amount to an advisory panel recommendation to approve Lilly's request to re-label and market Evista as a breast cancer reduction drug.

The FDA often follows the advice of its advisory panels, although it is not required to do so.

The panel based its recommendations on the results of four studies presented by Lilly, including results of a large National Cancer Institute Study examining Evista and an older drug tamoxifen, in relation to preventing breast cancer.

The study of nearly 20,000 postmenopausal women showed that Evista and tamoxifen cut the risk of women developing breast cancer by nearly 50%.

Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.