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Gilead (GILD) Gets FDA Nod for Trodelvy in Urothelial Cancer

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Gilead Sciences, Inc. GILD announced that the FDA has granted accelerated approval to Trodelvy (sacituzumabgovitecan-hziy) for a new indication. The drug is now approved for treating locally-advanced or metastatic urothelial cancer (“UC”) in adult patients who have previously received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The nod for UC indication marks the second FDA approval for Trodelvy.

This approval was based on data from the single-arm phase II TROPHY study, which evaluated Trodelvy in the given patient population. Notably, out of the 112 patients who were investigated for efficacy, 5.4% treated with Trodelvy experienced a complete response while 22.3% experienced a partial response. Also, the median duration of response was 7.2 months.

Per the company, around 83,000 people in the United States will be diagnosed with bladder cancer in 2021 and 90% of those diagnoses will be UC. Also, the relative five-year survival rate for patients with metastatic UC is 5.5%.

Hence, the approval for Trodelvy should be able to address an area of high unmet medical need.

Earlier this month, the FDA granted full approval to Trodelvy for adult patients with unresectable locally-advanced or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The regulatory body granted accelerated approval to Trodelvy in April 2020 based on an objective response rate and duration of response results in a phase I/II study.

The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy for metastatic TNBC in the European Union.

Shares of Gilead have rallied 11.3% so far this year against the industry’s decrease of 7%.

price chart for GILD
price chart for GILD


Please note that Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor– a protein frequently expressed in multiple types of epithelial tumors.

We remind investors that in October 2020, Gilead acquired Immunomedics for approximately $21 billion, which added Trodelvy to Gilead’s oncology portfolio. The massive decline in sales of its HCV franchise has led the company to focus on the HIV franchise and the oncology portfolio.

Zacks Rank & Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include ASLAN Pharmaceuticals Limited ASLN, Repligen Corporation RGEN and Nabriva Therapeutics AG NBRV, 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.

ASLAN Pharmaceuticals’ loss per share estimates have narrowed 33.3% for 2021 and 26.8% for 2022 over the past 60 days. The stock has surged 66.6% year to date.

Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 11% year to date.

Nabriva Therapeutics’ loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.

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