ï»¿Courtesy of the American Society of Hematology/Peter Maslak
ï»¿ï»¿Primary myelofibrosis in fibrotic stage
The label for ruxolitinib (Jakafi), the only FDA-approved agent for intermediate-risk and high-risk myelofibrosis, has been updated with dosing guidelines that are more flexible and extend treatment to patients with lower platelet counts. Safety information about progressive multifocal leukoencephalopathy (PML) also has been added.
The new recommendations call for a starting dose of 5 mg twice daily for patients with baseline platelet counts between 50–100 x 109/L (50,000 to 100,000). Depending on their response, patients with these starting platelet counts may receive up to 10 mg twice daily. The label retains a recommended starting dosage of 20 mg twice daily for patients with platelet counts greater than 200 x 109/L (200,000), and 15 mg twice daily for those with counts between 100-200 x 109/L (100,000-200,000).
For PML, the new label advises that treatment be halted and the patient evaluated if infection is suspected. There has been one known case of PML among approximately 9800 patients treated worldwide, although research suggests the risk of PML is higher among patients with myelofibrosis, according to Incyte Corporation, which markets ruxolitinib in the United States. http://goo.gl/mGnJI
More Bendamustine Data Sought
The FDA has issued a complete response letter on an application for a new liquid formulation of bendamustine HCL for Injection (Treanda), according to Teva Pharmaceutical Industry LTD. The company, which markets the drug in the United States, disclosed the action July 9 in a filing with the US Securities and Exchange Commission.
Teva said the agency has questions regarding stability data and that no additional studies are required. In fact, the company contends that the data are “already available and will work with the FDA to expedite this part of the process.”
Bendamustine was approved in 2008 for the treatment of indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen as well as for the treatment of chronic lymphocytic leukemia. Teva said that bendamustine remains “available and is safe and effective.”
Bexxar Discontinued as NHL Therapy
GlaxoSmithKline has announced that the company will discontinue the manu¬facture and sale of the Bexxar therapeutic regimen (tositumomab and iodine I 131 tositumomab) on February 20, 2014.
The Bexxar regimen was approved by the FDA in 2003 for the treatment of patients with CD20-positive, follicular, non-Hodgkin lymphoma (NHL), with and without transformation, who are rituximab-refractory, and whose disease has relapsed after treatment with chemotherapy. “The use of Bexxar has been extremely limited and is projected to continue to decline,” the company said in a statement, which also noted that new treat¬ment options have become available for patients with NHL.
For questions, physicians may call the GSK Response Center at 1-888-825-5249. http://goo.gl/H2uf3o