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Seattle Genetics' Adcetris Gets EU Nod for Label Expansion
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Seattle Genetics, Inc. and partner Takeda Pharmaceutical Company Limited, announced that the European Commission has extended the current conditional marketing authorization for an expanded indication for its lymphoma drug Adcetris (brentuximab vedotin). The marketing authorization is extended for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy.
The decision was based on the positive opinion issued by the Committee for Medicinal Products for Human Use on Nov 9, 2017.
We note that Adcetris is the only marketed product at Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma, and for patients suffering from classical Hodgkin lymphoma, who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Over a year, shares of Seattle Genetics have declined 8.6% as against the industry’s gain of 5.8%.
The marketing aurthorization is mainly based on positive data from the phase III trial, ALCANZA study in patients with cutaneous T-cell lymphoma (CTCL).
Interestingly, the ALCANZA study achieved both the primary and secondary endpoints. The study showed that CTCL patients treated with Adcetris had superior outcomes across all primary and secondary endpoints compared with patients in the control arm, who were treated with either methotrexate or bexarotene standard of care agents.
The marketing authorization for Adcetris is valid in 28 countries of the European Union.
In November 2017, the FDA has approved Adcetris for the treatment of primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides that have received prior systemic therapy. The approval was was based on positive data from the phase III trial, ALCANZA and two phase II investigator-sponsored trials in patients CTCL.
The label expansion is expected to boost the sales of the drug further. Evidently, sales of the drug in the third quarter grew 13% year over year to $79.2 million.
Furthermore, Seattle Genetics is developing the drug in more than 70 clinical studies with key studies including evaluation of T-cell lymphomas and Hodgkin lymphoma. Another phase III study is also evaluating Adcetris in frontline mature T-cell lymphomas. Again, the drug is being studied in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in relapsed/refractory Hodgkin lymphoma.
However, Adcetris faces competition from other drugs that include Merck & Co., Inc.’s (MRK - Free Report) Keytruda, which is also approved for the lymphoma indication.
Exelixis’ earnings per share estimates have moved up from 72 cents to 73 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average of 572.92%. Share price of the company surged 53.1% in the past one year.
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Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Seattle Genetics' Adcetris Gets EU Nod for Label Expansion
Seattle Genetics, Inc. and partner Takeda Pharmaceutical Company Limited, announced that the European Commission has extended the current conditional marketing authorization for an expanded indication for its lymphoma drug Adcetris (brentuximab vedotin). The marketing authorization is extended for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy.
The decision was based on the positive opinion issued by the Committee for Medicinal Products for Human Use on Nov 9, 2017.
We note that Adcetris is the only marketed product at Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma, and for patients suffering from classical Hodgkin lymphoma, who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Over a year, shares of Seattle Genetics have declined 8.6% as against the industry’s gain of 5.8%.
The marketing aurthorization is mainly based on positive data from the phase III trial, ALCANZA study in patients with cutaneous T-cell lymphoma (CTCL).
Interestingly, the ALCANZA study achieved both the primary and secondary endpoints. The study showed that CTCL patients treated with Adcetris had superior outcomes across all primary and secondary endpoints compared with patients in the control arm, who were treated with either methotrexate or bexarotene standard of care agents.
The marketing authorization for Adcetris is valid in 28 countries of the European Union.
In November 2017, the FDA has approved Adcetris for the treatment of primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides that have received prior systemic therapy. The approval was was based on positive data from the phase III trial, ALCANZA and two phase II investigator-sponsored trials in patients CTCL.
The label expansion is expected to boost the sales of the drug further. Evidently, sales of the drug in the third quarter grew 13% year over year to $79.2 million.
Furthermore, Seattle Genetics is developing the drug in more than 70 clinical studies with key studies including evaluation of T-cell lymphomas and Hodgkin lymphoma. Another phase III study is also evaluating Adcetris in frontline mature T-cell lymphomas. Again, the drug is being studied in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in relapsed/refractory Hodgkin lymphoma.
However, Adcetris faces competition from other drugs that include Merck & Co., Inc.’s (MRK - Free Report) Keytruda, which is also approved for the lymphoma indication.
Seattle Genetics, Inc. Price
Seattle Genetics, Inc. Price | Seattle Genetics, Inc. Quote
Zacks Rank & Stock to Consider
Seattle Genetics carries a Zacks Rank #3 (Hold).
A better-ranked stock from the health care space is Exelixis, Inc. (EXEL - Free Report) , carriying a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ earnings per share estimates have moved up from 72 cents to 73 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average of 572.92%. Share price of the company surged 53.1% in the past one year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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