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Seattle Genetics' Adcetris Gets FDA Nod for Label Expansion

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Seattle Genetics, Inc. SGEN announced the FDA approved an expanded indication for its lymphoma drug, Adcetris (brentuximab vedotin).

The company announced that the FDA has approved Adcetris for the treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) that have received prior systemic therapy. Notably, the approval was received a month before the action date set by the FDA (Dec 16, 2017).  

In August, the FDA granted priority review for the supplemental Biologics License Application (BLA) filed to get Adcetris approve for the above indications

Markedly, primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL) which is blood cancer of the skin

Adcetris is the only marketed product at Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL), 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.

So far this year, shares of Seattle Genetics have increased 9.8% compared with the industry’s gain of 2.3%.



The latest approval was mainly based on positive data from the phase III trial, ALCANZA and two phase II investigator-sponsored trials 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.

Going forward, the expanded label should further boost the sales of the drug. 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 in 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 Opdivo in relapsed/refractory Hodgkin lymphoma.

However, Adcetris faces competition from other drugs that include Merck & Co., Inc.’s MRK Keytruda, which was recently approved for the lymphoma indication.

Zacks Rank & Stock to Consider

Seattle Genetics carries a Zacks Rank #3 (Hold). A better-ranked health care stock in the same space is Ligand Pharmaceuticals Incorporated LGND sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 37.6% year to date.

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