AstraZeneca's Faslodex Recommended By CHMP For 1st Line Use

AstraZeneca PLC (NYSE:AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of Faslodex (fulvestrant) for 1st-line treatment for postmenopausal women with HR+ advanced breast cancer.

Presently, Faslodex is approved for advanced breast cancer in later lines of treatment. Faslodex is used to treat postmenopausal women with hormone receptor - positive metastatic breast cancer whose disease has spread after treatment with antiestrogen medicine. It is also is also approved, in combination with Pfizer Inc.’s (NYSE:PFE) Ibrance (palbociclib), for the treatment of women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine.

AstraZeneca is looking to get the drug approved for the treatment of HR+ locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-estrogen therapy.

AstraZeneca’s shares have outperformed the Zacks classified Large Cap Pharma industry so far this year. The company’s shares have gained 27.5% compared with the industry’s gain of 14.9%.

Coming back to the release, we note that the CHMP recommendation is based on positive data from the phase III FALCON study. Data from the study showed that Faslodex 500mg was more effective over Arimidex (anastrozole) 1mg in the treatment of locally-advanced or metastatic breast cancer in post-menopausal women, who had not received prior hormonal-based medicine for HR+ breast cancer. In addition, the study revealed that patients treated with Faslodex experienced 2.8 months longer delay in disease worsening or death than those treated with anastrozole.

Notably, the CHMP’s positive opinion will now be reviewed by the European Commission and the final decision will be applicable to all 28 the European Union (EU) member countries plus Iceland, Norway and Liechtenstein.

Also, in Mar 2017, Novartis AG (NYSE:NVS) announced that the FDA has approved Kisqali, formerly known as ribociclib (LEE011), for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

In May 2017, another company, Puma Biotechnology, Inc (NASDAQ:PBYI) announced that an FDA advisory committee recommended the approval of its lead pipeline candidate, neratinib for the treatment of some breast cancers. The FDA’s Oncologic Drugs Advisory Committee (ODAC) committee voted 12 - 4 to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early-stage breast cancer as a single agent.

Zacks Rank

AstraZeneca currently sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sell These Stocks. Now.

Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These are sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.

See today's Zacks "Strong Sells" absolutely free >>.