Seattle Genetics ($SGEN) can claim a victory today. An FDA panel of experts voted unanimously for accelerated approval of the developer's drug brentuximab vedotin (Adcetris) for patients with aggressive forms related blood cancers called Hodgkin lymphoma and anaplastic large cell lymphoma, according to multiple reports.
The FDA advisory committee's votes today followed what many industry watchers viewed as a mixed agency staff review of Seattle Genetics' application for approval of the drug for the two forms of blood cancer, in which questions were raised about whether the relatively small, single-arm trials that the company has completed to date show enough data of the drug's benefits. Yet those concerns didn't cause any of the advisory committee members to hold back from endorsing the drug's approval.
With the panel experts backing Adcetris, a lingering question might be whether Seattle Genetics will gain full approval of the drug from the FDA or a form of approval that would require studies to confirm that the drug works and is safe in patients. Still, the company seems well on its way to grabbing its first approval. Its drug could also become one of the first marketed antibody-drug conjugate treatments, which combine the selective binding capabilities of an antibody with the cancer-killing effects of a chemotherapy agent. As Xconomy's Luke Timmerman notes, Adcetris could become the first commercially successful drug in this class.
The FDA, of course, will take the recommendations from the advisory committee into account in its decision on approval expected later this summer, with a PDUFA date of Aug. 30.
- check out Feuerstein's coverage
- see the report from Reuters
- read Timmerman's article
Editor's note: This story has been updated to include the FDA panel's vote on the use of Adcetris in anaplastic large cell lymphoma. The drug could become one of the first antibody-drug conjugates to hit the market, but not the first as this story initially stated. The story was therefore also corrected.