Seattle Genetics, Inc.
) recently announced that the US Food and Drug Administration
(FDA) has accepted its supplemental biologics license application
(sBLA) seeking approval of Adcetris (brentuximab vedotin) for an
additional indication. The company is looking to get Adcetris
approved for retreatment and extended duration of medication with
the drug beyond 16 cycles in relapsed Hodgkin lymphoma (HL) and
systemic anaplastic large cell lymphoma (sALCL).
We remind investors that Seattle Genetics submitted the sBLA
to the FDA in Mar 2013 on the basis of encouraging data from a
phase II study. The study had two treatment arms. One arm
evaluated retreatment with Adcetris in patients who had responded
to Adcetris treatment earlier, then discontinued treatment and as
a result suffered disease progression or relapse. The other arm
evaluated prolonged treatment with Adcetris beyond 16 cycles of
medication. 70% of patients retreated with Adcetris and 88% of
patients with extended treatment with Adcetris achieved an
objective response. In both the settings, Adcetris was well
tolerated. A final decision from the FDA is expected by Sep 14,
2013 (action date).
We note that Adcetris was approved by the FDA in Aug 2011 for
the treatment of patients with HL after failure of autologous
stem cell transplant (ASCT) or after failure of at least two
prior multi-agent chemotherapy regimens in patients who are not
suitable for ASCT. Adcetris was also approved for sALCL in
We are positive on Seattle Genetics' efforts to expand
Adcetris' label. Successful label expansion should boost the
sales potential of the drug. Adcetris' net product revenue in the
first quarter of 2013 was $33.9 million. Adcetris is also being
evaluated in other indications.
Seattle Genetics carries a Zacks Rank #2 (Buy). Right now,
Anika Therapeutics Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
Myriad Genetics Inc.
) also carries Zacks Rank #2.
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