Seattle Genetics, Inc. (SGEN - Free Report) announced that the European Commission (EC) has approved to extend the current conditional marketing authorization for its lead marketed product, Adcetris. The drug is now approved in combination with CHP (cyclophosphamide, doxorubicin, prednisone) for addressing adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics’ collaborator in Europe, Takeda Pharmaceutical Company (TAK - Free Report) , has won this nod.
The approval was based on positive data from the phase III ECHELON-2 study, which demonstrated that treatment with Adcetris plus CHP led to superior progression-free survival and overall survival compared to CHOP chemotherapy in the given patient population.
Per the company, the approval of Adcetris plus CHP for patients with previously untreated sALCL represents a significant advance for those who were previously treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions in Europe.
In March 2020, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Adcetris, recommending its approval for the given indication.
Shares of Seattle Genetics have rallied 40.1% so far this year compared with the industry’s increase of 5.7%.
The FDA approved Adcetris for six different indications. The drug is also approved for several diseases in ex-U.S. markets.
Notably, Seattle Genetics has an agreement with Takeda for the development and commercialization of Adcetris. The company retains all the rights to sell Adcetris in the United States and Canada while Takeda has commercial rights to the drug in the rest of the world.
In the first quarter of 2020, Adcetris generated net sales worth $164.1 million in the United States and Canada, up 22% year over year. The drug is also being evaluated in several label expansion studies.
Meanwhile, Seattle Genetics is studying Adcetris in combination with Bristol-Myers’ (BMY - Free Report) Opdivo for treating Hodgkin and non-Hodgkin lymphoma. Successful development of the same and its potential approval will lend a major boost to the company.
Zacks Rank & Another Key Pick
Seattle Genetics currently holds a Zacks Rank #2 (Buy). Another top-ranked stock in the healthcare sector is Moleculin Biotech Inc (MBRX - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moleculin Biotech’s loss per share estimates have narrowed 11.1% for 2020 and 10.4% for 2021 over the past 60 days.
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