Novartis Files Femara Applications in North America and Europe for Indication as First Ever Post-Tamoxifen Treatment for Early Breast Cancer

BN003644 10 de maio de 2004 09:10 HORALOCAL

CIÊNCIA

Novartis Files Femara Applications in North America and Europe for Indication as First Ever Post-Tamoxifen Treatment for Early Breast Cancer

Submissions based on compelling data in postmenopausal women with early breast cancer; interim published data showed extended adjuvant treatment with Femara, following standard adjuvant (post-surgery) tamoxifen, cut risk of relapse nearly in half (43%)

BASEL, Switzerland, May 10 /PRNewswire/ -- Novartis has submitted marketing applications in the United States, European Union and Switzerland for the use of Femara(R) (letrozole) in the extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant (post-surgery) tamoxifen therapy and remained disease-free. These submissions mark the first time that data on a breast cancer therapy will be reviewed by health authorities for use of a medication following treatment with tamoxifen in the extended adjuvant setting.

The filings comprise results of the independent landmark MA-17 study, which was published expeditiously by the New England Journal of Medicine in the online edition on 9 October 2003. Updated results from the trial will be presented during the "Best of Oncology" session on Tuesday, 8 June, from 9:15-10:45 a.m. Central Time at the annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, Louisiana, USA.

The term extended adjuvant describes the period following standard adjuvant treatment with tamoxifen. During this stage, the ongoing risk of relapse remains significant for patients regardless of whether cancer cells were detected in the lymph nodes (called node positive) or not (node negative) at the time of diagnosis of early breast cancer. There is currently no clinically proven post-tamoxifen therapy available for the approximately one million women worldwide who take tamoxifen in any given year. Upon completion of tamoxifen therapy, these women are potential candidates for treatment with Femara.

"These filings represent a very important opportunity for Novartis Oncology to help fill a critical gap in breast cancer treatment," said Diane Young, MD, vice president, global head, Clinical Development, Novartis Oncology. "This is an important milestone in the clinical development program for Femara, and we look forward to the results of the BIG 1-98 early adjuvant study, which compares Femara and tamoxifen during the first five years of treatment after surgery. "

Data

The filings were based on final data from an international, double-blind, randomized, multi-center study which included nearly 5, 200 postmenopausal women with early breast cancer. The primary objective was to compare the disease-free survival of postmenopausal women taking Femara vs. placebo after approximately five years of post-surgery tamoxifen therapy. The interim published data showed, at a median interim follow-up of 28 months, that taking Femara after five years of adjuvant therapy with tamoxifen cut a woman's risk of recurrence nearly in half as compared with placebo (43% reduced risk of recurrence; P=0.00008).

In addition, the estimated absolute improvement in disease free survival at four years was 6% for patients taking Femara compared with placebo (93% vs. 87%). Disease free survival is defined as the time from randomization to the time of first recurrence of the primary disease in the breast (including contralateral breast), chest wall, nodal or metastatic sites.

The interim data from MA-17 were so compelling that last fall an Independent Data Safety Monitoring Committee and the investigators unblinded the study so patients taking placebo could be offered the opportunity to switch to Femara. These patients had been on placebo for up to five years (median 24 months) when they were offered to switch to Femara. They continue to be followed under an amended protocol. MA-17 is being coordinated by the National Cancer Institute of Canada Clinical Trials Group and supported by Novartis.

Breast cancer recurrence

Approximately one-third of women with estrogen receptor-positive early breast cancer experience a recurrence. Over half of these recurrences occur more than five years after surgery, according to the Early Breast Cancer Trialists Group, Oxford, UK. Currently, it is estimated that more than one million women worldwide take adjuvant tamoxifen, which is currently the "gold standard" hormonal therapy for postmenopausal women with receptor-positive early breast cancer for the first five years after surgery. However, tamoxifen therapy has not been shown to provide additional benefit after five years and, traditionally, most women have not received treatment after completion of tamoxifen therapy. MA-17 is the first study that has provided clinical evidence to support use of medication, Femara, to reduce the risk of breast cancer recurrence during this extended adjuvant time period.

Additional Femara adjuvant clinical trial

A Phase III early adjuvant study with Femara is being conducted by the Breast International Group (BIG 1-98) in collaboration with Novartis. This study has four treatment arms, comparing five years of Femara, five years of tamoxifen, two years of Femara followed by three of tamoxifen, and two years of tamoxifen followed by three years of Femara. More than 8,000 women have enrolled in this trial. Initial results from this study are expected by the end of the year.

Femara

Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Femara is currently available in more than 80 countries worldwide. Not all indications are available in every country.

Contraindications and adverse events

In the interim MA-17 analysis, the most common adverse events were hot flashes, sweating, edema, hypercholesterolemia, headache, arthralgia, myalgia, fatigue, constipation and dizziness, in greater than 10% of patients in either arm of the study. Of these, hot flashes, arthralgia, and myalgia were more common in those receiving Femara than placebo (P<0.05). Vaginal bleeding was more common in those taking placebo (P=0.01).

Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Femara is generally well tolerated. In a first-line registration trial versus the antiestrogen tamoxifen, the most commonly reported adverse events for Femara were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain (18% vs. 19%), nausea (17% vs. 17%), dyspnea or labored breathing (18% vs. 17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%), constipation (10% vs. 11%), chest pain (6% vs. 6%) and headache (8% vs. 6%). Femara may cause fetal harm when administered to pregnant women. There is no clinical experience to date on the use of Femara in combination with other anticancer agents. The incidence of peripheral thromboembolic events, cardiovascular events, and cerebrovascular events was 3-4% in each treatment arm.

The foregoing release contains forward-looking statements that can be identified by terminology such as "will be presented," "potential," "represent ... opportunity," "look forward to," "estimated," "are expected," or similar expressions, or by express or implied discussions regarding potential new indications for Femara or potential future sales of Femara, or regarding the long-term impact of a patient's use of Femara. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Femara will be approved for any additional indications in any market. Nor can there be any guarantee regarding potential future sales of Femara. Neither can there be any guarantee regarding the long-term impact of a patient's use of Femara. In particular, management's expectations regarding commercialization of Femara could be affected by, among other things, additional analysis of Femara clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

Additional information regarding Femara or Novartis

Oncology can contact the websites www.femara.com or www.novartisoncology.com or additional media information can be found at www.novartisoncologyvpo.com.

Internet Address: http://www.novartis.com

FONTE Novartis International AG
10/05/2004
CONTATO: Nadine Schecker, Novartis Global Communications,
Tel. +41 61 324 2710, Fax +41 61 324 9090,
nadine.schecker@group.novartis.com; Eric Althoff, Novartis
Pharma Communications, Tel. +41 61 324 6392, Fax
+41 61 324 2224, eric.althoff@pharma.novartis.com
Website: http://www.novartis.com


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