Article preview from "The Pink Sheet" DAILY 9/29/2009
Two of the four post-market studies Allos is required to conduct as part of Folotyn 's Sept. 24 accelerated approval could broaden the label of the oncologic, newly cleared for treatment of relapsed or refractory peripheral T-cell lymphoma. Read on...
Article preview from "The Pink Sheet" DAILY 9/29/2009
The post-marketing commitments include randomized Phase III trials of Folotyn in both first-line PTCL and in cutaneous T-cell lymphoma.
"It's worked out well," Allos Chief Commercial Officer Jim Caruso said in an interview. "It gives us the opportunity to have further understanding of Folotyn and its clinical utility, and at the same time advance treatment of T-cell lymphoma, as well as add two strategic elements to our three- to five-year product commercialization plan."
The front-line trial has a two stage design. Patients will be enrolled prior to initiating chemotherapy with a CHOP-based regimen; those patients that have either a complete or partial response to CHOP chemotherapy will be transferred to either Folotyn or followed for observation while receiving supportive care. The primary endpoint will be progression-free survival.
The trial in CTCL will compare treatment with Folotyn + Ligand Pharmaceuticals' Targretin (bexarotene) to treatment with Targretin alone in patients refractory to at least one prior systemic therapy. Like the front-line study, this trial is randomized - a trial design that FDA's Oncologic Drugs Advisory Committee voted was necessary for approval of future CTCL drugs. Targretin is one of four agents indicated to treat CTCL in the U.S.
The other two trials Allos is also required to conduct in the post-approval setting include a Phase I pharmacokinetic study in patients with renal impairment and a Phase I pharmacokinetic/pharmcodynamic trial of Folotyn + Targretin.
The firm has not released details on timing of the trials.
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