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Gilead (GILD) Gets FDA Nod for Trodelvy in Urothelial Cancer
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Gilead Sciences, Inc. (GILD - Free Report) 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%.
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.
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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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Gilead (GILD) Gets FDA Nod for Trodelvy in Urothelial Cancer
Gilead Sciences, Inc. (GILD - Free Report) 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%.
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 - Free Report) , Repligen Corporation (RGEN - Free Report) and Nabriva Therapeutics AG , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>