Gilead's (GILD) Breast Cancer Drug Trodelvy Gets FDA Nod
Gilead Sciences, Inc.GILD announced the approval of sacituzumab govitecan-hziy by the FDA for the treatment of metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults, who have previously been treated with endocrine-based therapy and additional systemic therapies.
The approval was based on results from the phase III TROPiCS-02 study which were statistically significant and clinically meaningful. Post the approval, the National Comprehensive Cancer Networkhas recommended Trodelvy as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer.
In the past year, the shares of Gilead Sciences have risen 32.5% against the industry’s fall of 9.4%.
Image Source: Zacks Investment Research
The phase III global, multicenter, open-label TROPiCS-02 met its primary endpoint with statistical significance, portraying a clinically meaningful overall survival benefit of about 3,2 months against chemotherapy. Additionally, a 34% reduction in risk of disease progression or death was also observed in patients treated with Trodelvy. 21% of patients treated with Trodelvy showed progression-free breast cancer at the one-year mark as opposed to 7% of those treated with chemotherapy.
Trodelvy was previously approved under accelerated approval in the United States by the FDA for the treatment of metastatic triple-negative breast cancer in April 2020 with full marketing approval received in April 2021, after the results from the confirmatory ASCENT study.
The European Medicines Agency has also validated a type II variation of the marketing authorization application for Trodelvy for the treatment of adult patients with pre-treated HR+/HER2- metastatic breast cancer.
HR+/HER2- breast cancer is observed in approximately 70% of all new cases, making it the most common type of breast cancer. Out of this 70%, approximately 1 out of 3 patients with early-stage breast cancer, become metastatic with a 30% five-year survival rate.
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class, Trop-2 directed antibody-drug conjugate, which stands approved in more than 40 countries and multiple additional regulatory reviews, currently in the process, worldwide for the treatment of metastatic breast cancer in adult patients. Trodelvy enjoys accelerated approval in the United States for the treatment of certain patients with second-line metastatic urothelial cancer. Studies for the potential label expansion of Trodelvy to treat metastatic non-small cell lung cancer, metastatic small cell lung cancer, head and neck cancer and endometrial cancer are also currently underway.
The company is working on diversifying and growing its business beyond antivirals into other therapeutic areas by inroads in the oncology space with strategic collaborations and acquisitions. It acquired oncology company Immunomedics for approximately $21 billion in 2020, which added the breast cancer drug Trodelvy to its portfolio.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
Zacks Rank and Other Stocks to Consider
Gilead Sciences currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biomedical market are 89BIO, Inc. ETNB, Adicet Bio, Inc. ACET and ADMA Biologics, Inc. ADMA, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for 89BIO’s 2022 loss per share has narrowed from $3.34 to $2.65. During the same period, the loss estimate per share for 2023 has narrowed from $3.59 to $2.59. In the past year, the shares of 89BIO have risen by 144.7%.
ETNB beat estimates in three out of the last four quarters, delivering an average earnings surprise of 10.08%.
In the past 90 days, the estimate for Adicet Bio’s 2022 loss per share has narrowed from $1.63 to $1.54. During the same period, the loss estimate per share for 2023 has narrowed from $2.25 to $2.09. In the past year, the shares of Adicet have decreased by 32.6%.
ACET’s earnings beat estimates in two of the trailing four quarters, delivering an average earnings surprise of 54.24%.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2022 loss per share has narrowed from 34 cents to 33 cents. During the same period, the loss estimate per share for 2023 has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 123.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Adicet Bio, Inc. (ACET) : Free Stock Analysis Report
ADMA Biologics Inc (ADMA) : Free Stock Analysis Report
89BIO (ETNB) : Free Stock Analysis Report
To read this article on Zacks.com click here.