Subscribe to Entrepreneur for $5
Subscribe

Gilead (GILD) Gets EU Nod for Breast Cancer Drug, Trodelvy

The European Commission grants marketing authorization to Gilead's (GILD) Trodelvy as a monotherapy for the second-line treatment of adults with metastatic triple-negative breast cancer.

By
This story originally appeared on Zacks

Gilead Sciences, Inc. GILD announced that the European Commission has granted marketing authorization to Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for advanced disease.

- Zacks

Please note that Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor. The drug is already approved in the United States for the TNBC indication.

The nod in Europe was based on data from the phase III ASCENT study. Data from the study showed that treatment with Trodelvy reduces the risk of death by 49% and improves median overall survival to 11.8 months as compared to 6.9 months with physician’s choice of chemotherapy.

The approval of Trodelvy in the EU was expected, since in October 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion on the drug, recommending approval for the same for the treatment of second-line TNBC.

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.

Shares of Gilead have rallied 21.2% so far this year against the industry’s decrease of 16.4%.

Zacks Investment ResearchImage Source: Zacks Investment Research

We remind investors that in October 2020, Gilead acquired Immunomedics for approximately $21 billion, which added Trodelvy to its oncology portfolio. The drug generated sales worth $262 million in the first nine months of 2021. The latest approval in Europe, along with potential label expansion, will boost Trodelvy sales in the days ahead.

Trodelvy is also approved in the United States for treating locally-advanced or metastatic urothelial cancer in adult patients who have previously received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.

In October 2021, Gilead inked a collaboration and supply agreement with Merck MRK to evaluate the efficacy of Trodelvy in combination with the latter’s anti-PD-1 therapy, Keytruda (pembrolizumab), as a first-line treatment for patients with locally advanced or metastatic TNBC.

The decline in its HCV business has forced Gilead to diversify into the oncology space, which promises potential despite stiff competition.

HIIV therapy Biktarvy continues to drive growth despite the ongoing impact of the pandemic. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance.

Competition is stiff in the HIV market as well from the likes of GlaxoSmithKline GSK, among others.

GlaxoSmithKline reported 8% growth in its HIV franchise in the third quarter, driven by its new HIV products Dovato, Juluca, Rukobia and Cabenuva.

To further strengthen its HIV franchise, Gilead has collaborated with a subsidiary of Merck to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.

Zacks Rank & Stock to Consider

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Precision BioSciences, Inc. DTIL, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Precision BioSciences’ loss per share estimates have narrowed 44.4% for 2021 and 20.1% for 2022, over the past 60 days. The stock has rallied 13.8% year to date.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters.



Zacks’ Top Picks to Cash in on Artificial Intelligence

This world-changing technology is projected to generate $100s of billions by 2025. From self-driving cars to consumer data analysis, people are relying on machines more than we ever have before. Now is the time to capitalize on the 4th Industrial Revolution. Zacks’ urgent special report reveals 6 AI picks investors need to know about today.

See 6 Artificial Intelligence Stocks With Extreme Upside Potential>>

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

 

GlaxoSmithKline plc (GSK): Free Stock Analysis Report

 

Merck & Co., Inc. (MRK): Free Stock Analysis Report

 

Gilead Sciences, Inc. (GILD): Free Stock Analysis Report

 

Precision BioSciences, Inc. (DTIL): Free Stock Analysis Report

 

To read this article on Zacks.com click here.