Seattle Genetics, Inc. SGEN announced that the FDA has approved its supplemental Biologics License Application seeking label expansion of Adcetris to include treatment of treatment-naive stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. The decision comes more than one month earlier than expected.
The FDA also approved the conversion of accelerated approval of Adcetris to regular approval for treatment of systemic anaplastic large cell lymphoma (sALCL) in patients who have failed at least one multi-agent chemotherapy regimen therapy.
The approvals came on the basis of a head-to-head study, ECHELON-1, of Adcetris plus chemotherapy compared to current standard of care.
Seattle Genetics’ shares have returned 2.5% so far this year against the industry’s decline of 0.9% in the period.
The phase III ECHELON-1 study evaluated Adcetris in combination with a chemotherapy regimen, AVD (Adriamycin, vinblastine and dacarbazine), against ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine), the current standard of care chemotherapy regimen for treatment of newly diagnosed advanced cHL.
Data from the study showed that Adcetris combination therapy achieved statistically significant improvement in progression-free survival (“PFS”) compared to ABVD. The combination therapy reduced the risk of progression, death or need for additional anticancer therapy by 23% in patients who did not achieve complete remission.
The overall survival (“OS”) rate was favorable for the Adcetris regimen. However, it did not show significant difference. Complete remission was achieved in 73% of the patients treated with Adcetris regimen compared with 70% for ABVD therapy.
Per the American Cancer Society, approximately half of 8,500 newly diagnosed patients with Hodgkin lymphoma in the United States will have Stage III/IV disease.
Adcetris was already approved in four indications including second or later line treatment for cHL. The drug is the only marketed drug of the company and a major revenue generator. The label expansion will certainly boost its prospects going forward.
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.
Seattle Genetics, Inc. Price
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Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #4 (Sell).
Horizon Pharma Public Limited Company HZNP is a better-ranked stock in the pharma sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Horizon Pharma’s earnings estimates increased 10% to $1.43 for 2018 and 15% to $1.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
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