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Jan24
Ortho Biotech Submitted USFDA sNDA for DOXIL® as Combination to VELCADE® for Treatment of Relapsed/Refractory Multiple Myeloma

The USFDA has accepted Ortho Biotech Products, L.P.(4336966)’s Supplemental New Drug Application (sNDA) for DOXIL® (doxorubicin HCl liposome injection) as combination therapy with VELCADE® (bortezomib) for injection to treat multiple myeloma patients who have received at least one prior therapy.

DOXIL.gifDOXIL® is currently indicated for the treatment of ovarian cancer patients whose disease has progressed or recurred after platinum-based chemotherapy while VELCADE® is the market leader in relapsed multiple myeloma.

According to Craig Tendler, M.D., Vice President, Clinical Affairs, Ortho Biotech:

"We are pleased that the FDA has accepted our sNDA, as this promising ombination would provide an expanded treatment option for patients with elapsed/refractory multiple myeloma.”

DOXIL is marketed in the United States by Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag while Schering-Plough Corporation has exclusive rights to market the medication as CAELYX® throughout the rest of the world (excluding Japan).

Find more details from the press release.


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« SQ109: Sequella, Inc.’s TB Drug Candidate, Received USFDA Fast Track Status | Main | Wyeth Pharmaceuticals Received USFDA Approvable Letter for Pristiq™ (desvenlafaxine succinate) as Treatment for Adult Major Depressive Disorder (MDD) Patients »

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