Millennium Pharmaceuticals has won approval from the US Food and Drug
Administration to expand the use of its best-selling cancer drug Velcade as a treatment for an aggressive form of non-Hodgkin’s lymphoma.
Velcade (bortezomib), which is approved to treat multiple myeloma, has now been given the green light from the FDA to be used as a treatment for
mantle cell lymphoma. Around 10,000 Americans suffer from MCL and median life expectancy following the first relapse is one to two years, said
Millennium, which noted that the approval was based on a trial of 155
patients with advanced MCL who had failed at least one previous therapy.
Although MCL is a relatively uncommon form of non-Hodgkin’s lymphoma, this latest approval is likely to give a boost to sales of Velcade, which is
Millennium’s main revenue driver and the drug is expected to add $225-$250 million to earnings this year. The news saw the firm’s shares edge up around 1.5% to $11.42.
Promising combination data
Millennium has also reported preliminary data at the American Society of
Hematology meeting in Orlando, from a Phase III trial in newly-diagnosed
multiple myeloma patients treated with Velcade in combination with
dexamethasone before stem cell transplantation. The data showed that the combination achieved a complete and near complete response rate of 20%, greater than a two-fold improvement over the vincristine, adriamycin and dexamethasone triplet, a commonly used therapy.