FDA alters safety information for mantle cell drug Velcade


The FDA has made two significant changes to the dosage and safety information for the mantle cell lymphoma drug bortezomib (Velcade), which is also indicated for patients with relapsed or refractory multiple myeloma.

The first change reflects Velcade's increased risk of toxicity by recommending a reduced initial dosage for patients with moderate-to-severe hepatic impairment.

The second change features data from a clinical study indicating "a higher median survival rate in patients using a combination of bortezomib, melphalan, and prednisone versus a regiment of just melphalan and prednisone (P=0.00084)."

Source: Medpage Today

By Ross Bonander

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