Seattle Genetics Inc.'s Adcetris (brentuximab) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The drugmaker announced the receipt of a breakthrough therapy designation just one month earlier for the CD30-directed antibody-drug conjugate based on Phase III ECHELON-1 trial. (Also see "Keeping Track: Flexion's Non-Opioid Knee Pain Drug Gets OK, Botox Gets Another Approval" - Pink Sheet, 8 October, 2017.) Assuming a priority review, the sBLA would be positioned for an approval decision by May 2018 or earlier. Adcetris is currently approved for the treatment of Classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma. FDA is also reviewing an sBLA for the drug under priority status for the treatment of patients with cutaneous T-cell lymphoma (CTCL), which has a Dec. 16, 2017 user fee goal date. (Also see "Keeping Track: Oncology Stays Hot With Besponsa And Lynparza Approvals; New Uses Of Adcetris, Cabometyx Submitted" - Pink Sheet, 19 August, 2017.)

Keeping Track: New MCL Treatment Calquence, Submissions Galore, And A Breakthrough Designation For GSK

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