Novartis: Femara endorsed by NICE for postmenopausal women with early breast cancer

By E. Janene Geiss

Philadelphia, Aug. 11 - Novartis AG said Friday that the National Institute for Health and Clinical Excellence (NICE) published a positive final appraisal document on the class of breast cancer drugs known as aromatase inhibitors post surgery.

This final decision from the national institute should ensure appropriate access to these latest life-saving treatments for the hundreds of thousands of postmenopausal women with breast cancer, according to a company news release.

Up until now, tamoxifen has been considered the "gold standard" treatment in this setting.

Femara (letrozole) has been recommended for post-surgery and extended adjuvant (after five years of tamoxifen therapy) use in early invasive oestrogen receptor-positive (ER+) breast cancer in postmenopausal women, in accordance with its licensed indications, officials said.

About 75% of all breast cancers in postmenopausal women are ER+.

Femara is the only aromatase inhibitor that these women can use before surgery, as initial treatment immediately after surgery, or after they have completed five years of tamoxifen therapy, officials said.

The company said that Femara has demonstrated greater benefit in women at increased risk of breast cancer recurrence.

The BIG 1-98[2] trial demonstrated this increased effectiveness in high-risk women, with a 29% reduction in risk of recurrence in women whose cancer had spread to the lymph nodes compared with tamoxifen, officials said.

Another trial, known as MA-17, demonstrated the efficacy of extended adjuvant Femara use.

Women taking Femara after five years of tamoxifen on the trial had their risk of breast cancer recurring reduced by 42%.

To address the lack of head-to-head data with aromatase inhibitors, Novartis said it recently started the FACE (Femara vs. Anastrozole Clinical Evaluation) trial.

This is the first head-to-head study of these two aromatase inhibitors in the post-surgery setting and is expected to enroll 4,000 women worldwide.

The trial will directly compare the efficacy of the two drugs in node positive patients who are at higher risk of their breast cancer returning.

Novartis is a Basel, Switzerland, pharmaceutical company.

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