Theravance Inc (THRX), GlaxoSmithKline plc (ADR) (GSK): Investors Should Brace for a Busy Week From the Biotech Sector

Since Perjeta was already approved by the FDA as a late-stage treatment for HER2-positive breast cancer in June 2012, and its safety and efficacy data in the aforementioned trials handily met its goals, I don’t see why Perjeta shouldn’t get a round of positive opinions from the FDA’s panel this week.

Adcetris
Finally, Seattle Genetics, Inc. (NASDAQ:SGEN) is expected to receive word from the FDA on the approval or rejection of its sBLA for Adcetris on or before Sept. 14.

Adcetris, Seattle Genetics, Inc. (NASDAQ:SGEN)’ only FDA-approved drug, gained its approval in August 2011 as a treatment for Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma (ALCL). When it was approved, ALCL patients had a particularly strong response in trials, with 88% experiencing a complete or partial response that lasted, on average, 12.6 months.

Adcetris’ new proposed indication would allow it to be used in cases of retreatment and in extended duration trials beyond 16 cycles for Hodgkin’s lymphoma and ALCL patients. Of the 23 patients retreated with Adcetris in trials, 70% achieved an objective response, of which nine had a complete remission. With regard to utilizing Adcetris as an extended treatment, the 17 patient study in which patients were treated for an average duration of 17.3 months demonstrated an even higher objective response rate of 88% with 76% showing a complete remission.

As in the prior two cases, the data seems to overwhelmingly favor a positive outlook from the FDA – in this case an approval. With overall revenue growth for Seattle Genetics, Inc. (NASDAQ:SGEN) having slowed to 15%, this could be just the type of boost needed to support its rallying share price.

The article Investors Should Brace for a Busy Week From the Biotech Sector originally appeared on Fool.com and is written by Sean Williams.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong. The Motley Fool recommends Seattle Genetics.

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