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Bortezomib (Velcade) Granted Priority Review Status for Patients With Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review of Millennium Pharmaceuticals Inc.'s drug Velcade (bortezomib) to treat new cases of multiple myeloma (MM). The priority review puts the new use of Velcade on track for possible approval in the first half of 2008, company officials said.
The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the Phase III VISTA study (covered in February’s issue of Oncology & Biotech News
), a large, well-controlled international clinical trial, comparing a Velcade-based regimen to a traditional standard of care. Velcade is currently indicated for MM and mantle cell lymphoma patients who have received at least one prior therapy. With priority review status, the FDA will make its decision on whether to approve the application within six months, rather than within the usual 10- to 12-month review period. Millennium says that a decision on the application is expected by June. Velcade is currently approved to treat patients with MM who have received at least one prior therapy.
The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development. The trial compared Velcade, melphalan, and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation -negative complete remission rate of 35%, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM compared with 5% in the MP arm.
Multiple myeloma is the second most common hematological malignancy and, although the disease is predominantly a cancer of the elderly (the median age of onset is 70 yr), recent statistics indicate both increasing incidence and younger age of onset. In the United States, more than 55,000 individuals have MM and approximately 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
Reports from American Society of Hematology: Advances in Thrombosis
The association between cancer and thrombosis is well recognized. Historically, bleeding disorders have been a key area of concern for hematologist oncologists.
At an on-site press conference detailing an overview of major blood clotting and bleeding disorder findings presented at ASH 2007, Andrew Schafer, MD, President, American Society of Hematology, and Chairman, Department of Medicine, New York Presbyterian-Weill Cornell Medical Center, New York City, affirmed “exciting breakthroughs in the treatment and approach to mitigating the risk of thrombosis and bleeding disorders, which will directly impact the quality of treatment for many patients.”
Dr. Weiss, Scientific Co-Chair of ASH 2007, asserted that “the most major news in the platelet field” delivered at ASH 2007, was comprised of “pretty important data relating to ITP (therapy),” which “has been difficult to treat by standard methods.” According to Dr. Weiss, a handful of potential new treatments “were talked about a lot.” One example cited by Dr. Weiss was product candidate AMG 531(Romiplostim/N-plate). The investigational drug AMG 531, explained Dr. Weiss, is thrombopoietin mimetic, acting by stimulating platelet production at the thrombopoietin receptor. Several presentations were devoted to promising AMG 531–related findings.
AMG 531 Demonstrates Efficacy in Sustaining Platelet Counts in Splenectomized Patients With Chronic Immune Thrombocytopenic Purpura in Phase III Study
Terry Gernsheimer, MD, University of Washington School of Medicine, Seattle, presented the results of a randomized, doubleblind, placebo-controlled phase III study, in which investigators evaluated the efficacy and safety of AMG 531 (Romiplostim/ N-plate) in previously splenectomized patients with chronic immune thrombocytopenic purpura (ITP) per ASH guidelines and baseline platelet counts <30,000/AμL.
Sixty-three splenectomized patients were enrolled (placebo, 21; AMG 531, 42), with a median age of 52 years (range 26–88) and a mean baseline platelet count 14.7x109/L. Subcutaneous AMG 531 or placebo was administered weekly for 24 weeks at a starting dose of 1μg/kg, and adjusted to maintain a target platelet count of 50-200x109/L.