Gilead’s Trodelvy Basks In TROPiCS With FDA Breast Cancer Nod

Company Lays Out Development Strategy In Q4 Earnings

Gilead’s big push into oncology bore more fruit with the FDA approval of Trodelvy based on the TROPiCS-02 trial. More development catalysts lie ahead for 2023, company said in its earnings.

Gilead announced the approval of Trodelvy for HR+/HER2- metastatic breast cancer • Source: Shutterstock

The ink was barely dry on Gilead Sciences, Inc.’s latest earnings report when the company announced another important milestone, the US Food and Drug Administration approval of Trodelvy (sacituzumab govitecan-hziy) based on survival data from the closely watched TROPiCS-02 trial in pretreated HR-positive/HER-negative metastatic breast cancer (HR+/HER2- mBC). The nod is the latest victory the drug maker has chalked up thanks to the large R&D program it also highlighted in its earnings report.

Gilead announced on 3 February the approval of Trodelvy for HR+/HER2 mBC in patients who have received endocrine-based therapy and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

What Incyte Investors Expect From New CEO Bill Meury

 

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By 

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Executives On The Move: New CEO At Atalanta Therapeutics

Recent moves in the industry include C-suite changes at Atalanta Therapeutics and Climb Bio, plus seven companies get new CMOs.