Shares in Seattle Genetics (Nasdaq: SGEN) are up nearly 5% and climbing today after the firm announced a new approval for Adcetris (brentuximab vedotin), shortly after revealing the US regulator had granted the therapy Breakthrough Designation in the same indication.
The approval is for a combination of the antibody-drug conjugate and chemotherapy for certain adults with peripheral T-cell lymphomas (PTCL), in the first-line setting.
The green light was given based on the successful outcome of the Phase III ECHELON-2 study, and was granted in record time under a US Food and Drug Administration pilot program.
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