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Seagen (SGEN) Gets Regular Approval, Label Expansion for Padcev
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Seagen and its partner Astellas Pharma Inc. announced that the FDA has approved two supplemental biologics license applications (“sBLA”) seeking label expansion for Padcev (enfortumabvedotin-ejfv).
Padcev was granted accelerated approval in 2019 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who previously received a PD-1/L1 inhibitor and platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.
The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only drug approved by the FDA to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin. The agency granted regular approval and a label expansion of the drug based on two sBLAs reviewed under the Real-Time Oncology Review pilot program.
We remind investors that in April 2021, the FDA accepted the above-mentioned sBLAs for Padcev, with a PDUFA date of Aug 17, 2021.
The above-mentioned first and second approvals are based on data from the second cohort of the EV-301 study (n=608) and phase II EV-201 study (n=125), respectively.
Shares of Seagen have declined 15.2% so far this year compared with the industry’s 1% decrease.
Image Source: Zacks Investment Research
The drug’s sales in first-quarter 2021 were up 1.2% sequentially to $69.8 million. The company is also investigating the drug in combination with Merck’s (MRK - Free Report) Keytruda in several mid-stage studies in first- and second-line metastaticurothelial cancer as well as muscle invasive bladder cancer. The current and potential label expansion of the drug is expected to cater to a wider market, which will boost its revenue prospects in the future.
The European Medicines Agency has already accepted the marketing authorization application for the drug to treat advanced/metastatic urothelial cancer in adult patients having received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant locally advanced or metastatic setting.
BioNTech’s earnings estimates for 2021 have increased from $20.14 to $30.58 per share in the past 60 days while that of 2022 has risen from $8.70 to $24.90 over the same period. The stock has surged 166.7% this year so far.
Bayer’s earnings estimates for 2021 have increased from $1.74 to $1.81 per share in the past 60 days while that of 2022 has risen from $1.89 to $2.00 over the same period. The stock has risen 2% in the year so far.
Image: Bigstock
Seagen (SGEN) Gets Regular Approval, Label Expansion for Padcev
Seagen and its partner Astellas Pharma Inc. announced that the FDA has approved two supplemental biologics license applications (“sBLA”) seeking label expansion for Padcev (enfortumabvedotin-ejfv).
Padcev was granted accelerated approval in 2019 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who previously received a PD-1/L1 inhibitor and platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.
The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only drug approved by the FDA to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin. The agency granted regular approval and a label expansion of the drug based on two sBLAs reviewed under the Real-Time Oncology Review pilot program.
We remind investors that in April 2021, the FDA accepted the above-mentioned sBLAs for Padcev, with a PDUFA date of Aug 17, 2021.
The above-mentioned first and second approvals are based on data from the second cohort of the EV-301 study (n=608) and phase II EV-201 study (n=125), respectively.
Shares of Seagen have declined 15.2% so far this year compared with the industry’s 1% decrease.
Image Source: Zacks Investment Research
The drug’s sales in first-quarter 2021 were up 1.2% sequentially to $69.8 million. The company is also investigating the drug in combination with Merck’s (MRK - Free Report) Keytruda in several mid-stage studies in first- and second-line metastaticurothelial cancer as well as muscle invasive bladder cancer. The current and potential label expansion of the drug is expected to cater to a wider market, which will boost its revenue prospects in the future.
The European Medicines Agency has already accepted the marketing authorization application for the drug to treat advanced/metastatic urothelial cancer in adult patients having received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant locally advanced or metastatic setting.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the medical sector include BioNTech (BNTX - Free Report) and Bayer (BAYRY - Free Report) . WhileBioNTech carries a Zacks Rank #1 (Strong Buy), Bayer currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioNTech’s earnings estimates for 2021 have increased from $20.14 to $30.58 per share in the past 60 days while that of 2022 has risen from $8.70 to $24.90 over the same period. The stock has surged 166.7% this year so far.
Bayer’s earnings estimates for 2021 have increased from $1.74 to $1.81 per share in the past 60 days while that of 2022 has risen from $1.89 to $2.00 over the same period. The stock has risen 2% in the year so far.
Seagen Inc. Price
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