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http://www.prnewswire.com/mnr/treanda/32349/.
"TREANDA is an important new treatment for patients with chroniclymphocytic leukemia, and this first-cycle approval by FDA represents asignificant milestone in the growth of our oncology business," said Dr. LesleyRussell, Executive Vice President, Worldwide Medical and RegulatoryOperations. "With a strong pipeline of near- and longer-term opportunities,Cephalon Oncology is poised to deliver therapies that target both hematologiccancers and solid tumors for patients in need of new options."
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Dr. Bruce Cheson, Clinical Professor of Hematology/Oncology, GeorgetownUniversity School of Medicine, Washington D.C., stated, "Patients with chroniclymphocytic leukemia can often live normal lives for many years because oftreatments that control the disease over the long-term. TREANDA is aneffective new option that offers a delay in disease progression, an importantgoal for patients with chronic lymphocytic leukemia."
In a randomized, international, multicenter, open-label pivotal study of301 treatment-naive patients with CLL, those who received TREANDA had betterclinical outcomes compared to patients treated with chlorambucil, anFDA-approved chemotherapy for patients with CLL. Specifically, TREANDApatients had a significantly higher overall response (59 percent of patientsresponded to TREANDA and 26 percent of patients responded to chlorambucil; p <0.0001). Patients who received TREANDA also had a higher complete responserate than those treated with chlorambucil (8 percent vs. <1 percent), whichmeans that after treatment with TREANDA, some patients had no signs of diseasein their blood.
Importantly, TREANDA patients also had a significantly longer progression-free survival (18 months vs. 6 months; Hazard Ratio = 0.27; p < 0.0001),meaning the disease did not get worse for a significant period of time. Theresponse to TREANDA lasted longer (duration of response) than in patients whoreceived chlorambucil (19 months vs. 7 months). The most common adverseevents in the trial were myelosuppression, fever, nausea, and vomiting.
TREANDA has been granted orphan drug status by the FDA for the treatmentof CLL. The orphan drug designation will provide marketing exclusivity inthis indication until March 2015.
About TREANDA
TREANDA has a unique chemical structure with two primary components, analkylating group and a benzimidazole component. Preclinical data suggest thatTREANDA can lead to cell death via several pathways. TREANDA damages the DNAin cancer cells, which leads to cell death by a process known as apoptosis(programmed cell death) as well as by an alternate cell death (non-apoptotic)pathway known as mitotic catastrophe (a disruption of normal cell division).The exact mechanism of action of TREANDA remains unknown.
In December 2007, Cephalon submitted an NDA requesting approval of TREANDAfor the treatment of patients with indolent (slow-growing) non-Hodgkin'slymphoma who have progressed during or following treatment with rituximab or arituximab-containing regimen and anticipates a review decisio
