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Seattle Genetics’ Adcetris Gets EC Nod for Label Expansion


Seattle Genetics, Inc. SGEN announced that its Japanese partner, Takeda Pharmaceutical Company Limited received approval from the European Commission (EC) to extend the marketing authorization for Adcetris (brentuximab vedotin) to include the combination of the drug and AVD (Adriamycin, vinblastine and dacarbazine) for the treatment of adult patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma (HL).

As a result, Seattle Genetics will receive a milestone payment of $30 million from Takeda. Adcetris in combination with AVD is also approved in the United States for treatment of adult patients with previously untreated stage III or IV classical HL.

The approval was supported by positive results from the ECHELON-1 phase III study.

Seattle Genetics’ shares have returned 27.2% in the past year, against the industry’s decline of 16.2%.

Adcetris is the only marketed product of Seattle Genetics. The drug is approved for relapsed HL and relapsed systemic anaplastic large cell lymphoma (sALCL) in the United States, the EU and Japan.

It is also approved in the United States and Europe for the treatment of patients suffering from cHL with no prior treatment and who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. It is also approved for primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) in the United States.

Seattle Genetics has an agreement with Takeda for further development and commercialization of Adcetris. Seattle Genetics retains all rights to sell Adcetris in the United States and Canada, while Takeda has commercial rights to the drug in the rest of the world.

However, the drug has several competitors, including Bristol-Myers Squibb’s BMY Opdivo and Merck’s MRK Keytruda, which are approved for relapsed or refractory cHL.

Zacks Rank & Stock to Consider

Seattle Genetics currently carries a Zacks Rank #5 (Sell).

A better-ranked stock worth considering is Novo Nordisk A/S NVO, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novo Nordisk’s earnings per share estimates have increased from $2.56 to $2.58 for 2019 and from $2.77 to $2.81 for 2020 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 1.70%.

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