Takeda Pharmaceutical Co has won an important expanded regulatory approval in the USA for Velcade, the cancer blockbuster that the Japanese drugmaker got control of with its recent acquisition of Millennium.

The US Food and Drug Administration has approved Velcade (bortezomib) for patients with previously untreated multiple myeloma, having been marketed before for MM and mantle cell lymphoma patients who had received at least one prior therapy. The expanded approval is based on the 682-patient VISTA trial which found that 30% of previously-untreated patients showed complete remission of their cancer after receiving Velcade, compared with 4% on standard therapy.

Importantly, patients treated with bortezomib also experienced a survival benefit, according to Paul Richardson, a senior investigator for the study and clinical director of the Jerome Lipper Multiple Myeloma Center. Multiple myeloma is the second most common haematological malignancy, Takeda noted, and between 2001-2005, the median age of diagnosis was 70 years. At the beginning of 2005, there were 56,200 individuals living with MM in the USA.

The FDA’s move is expected to provide a major boost to Velcade, which is marketed outside the USA by Johnson & Johnson and had revenues which touched $800 million last year. $265 million of that total came from the USA.

The expanded approval gives Velcade an advantage over Celgene Corp's rival drug Revlimid (lenalidomide) which is not approved as an initial therapy. Analysts believe that US sales of the compound could comfortably top $1 billion in the next five years, dependent on approvals for additional indications.