Seagen Inc. along with Japanese partner Astellas Pharma, Inc announced that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for their antibody-drug conjugate (“ADC”), enfortumab vedotin. The MAA is seeking review of enfortumab vedotin for the treatment of advanced/metastatic urothelial cancer in adult patients having received a PD-1/PD-L1 inhibitor, and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant locally advanced or metastatic setting.
Notably, enfortumab vedotin will be reviewed under the EMA’s accelerated assessment program. If approved, enfortumab vedotin will become the first ADC to be approved in the European Union for treating urothelial cancer.
The MAA was based on data from the global phase III EV-301 study which evaluated enfortumab vedotin for the given indication.
Please note that, in December 2019, the FDA granted an accelerated approval to Padcev (enfortumab vedotin-ejfv) for the treatment of patients with advanced/metastatic urothelial cancer, having been previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
Padcev, in combination with Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda, is also being investigated in several mid-stage studies in earlier-line settings of urothelial cancer as well as muscle invasive bladder cancer. Several other label expansion studies on Padcev are also currently underway.
Padcev generated revenues of $222.4 million in 2020. Potential label expansion and a potential nod in the EU of the drug will boost sales further in 2021.
We note that Seagen is working on the advancement of its ADC pipeline.
In February 2021, the European Commission granted marketing authorization to Seagen’s Tukysa (tucatinib) in combination with Roche's (RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine). The drug combo is approved for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer, and who have received at least two prior anti-HER2 treatment regimens.
Also, during the same month, Seagen, along with Danish partner Genmab A/S (GMAB - Free Report) , submitted a biologics license application to the FDA, seeking accelerated approval for the investigational ADC, tisotumab vedotin, for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy. A successful development of the same will be a boost for the company.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Seagen Inc. along with Japanese partner Astellas Pharma, Inc announced that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for their antibody-drug conjugate (“ADC”), enfortumab vedotin. The MAA is seeking review of enfortumab vedotin for the treatment of advanced/metastatic urothelial cancer in adult patients having received a PD-1/PD-L1 inhibitor, and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant locally advanced or metastatic setting.
Notably, enfortumab vedotin will be reviewed under the EMA’s accelerated assessment program. If approved, enfortumab vedotin will become the first ADC to be approved in the European Union for treating urothelial cancer.
The MAA was based on data from the global phase III EV-301 study which evaluated enfortumab vedotin for the given indication.
Please note that, in December 2019, the FDA granted an accelerated approval to Padcev (enfortumab vedotin-ejfv) for the treatment of patients with advanced/metastatic urothelial cancer, having been previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
Padcev, in combination with Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda, is also being investigated in several mid-stage studies in earlier-line settings of urothelial cancer as well as muscle invasive bladder cancer. Several other label expansion studies on Padcev are also currently underway.
Padcev generated revenues of $222.4 million in 2020. Potential label expansion and a potential nod in the EU of the drug will boost sales further in 2021.
We note that Seagen is working on the advancement of its ADC pipeline.
In February 2021, the European Commission granted marketing authorization to Seagen’s Tukysa (tucatinib) in combination with Roche's (RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine). The drug combo is approved for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer, and who have received at least two prior anti-HER2 treatment regimens.
Also, during the same month, Seagen, along with Danish partner Genmab A/S (GMAB - Free Report) , submitted a biologics license application to the FDA, seeking accelerated approval for the investigational ADC, tisotumab vedotin, for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy. A successful development of the same will be a boost for the company.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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