Millennium scores FDA OK on new Velcade administration

Millennium has scored a significant new FDA approval based largely on serendipity.  

After a French nurse successfully injected the intravenous drug Velcade under the skin of a patient whose veins were out of reach, the company went on to show in a Phase III study that subcutaneous injections of the multiple myeloma drug were effective and also helped significantly reduce one of the major side effects associated with the treatment. And that is likely to help beef up sales for the Takeda Pharmaceutical subsidiary, an active cancer drug developer that relies on its substantial Velcade income to fund new research.

The data showed that 57% of patients getting the subcutaneous injection experienced severe side effects, which forced 22% of the patients to stop taking it. And that's significantly better than the 70% of IV patients experiencing side effects with 27% dropping out.

"We'll have more patients that can stay on Velcade longer," Millennium CEO Deborah Dunsire told Bloomberg. "That could be a reason for sales to expand."

In addition to expanding its patient base, the new approach will allow medical assistants to administer the drug.

- here's the press release
- here's the story from Bloomberg 

Suggested Articles

Reata’s bardoxolone improved kidney function in a phase 3 trial of patients with a rare form of chronic kidney disease.

The suit alleges the FDA imposed the hold “without notice or explanation” and has since “rebuffed” Regenxbio’s repeated requests for an explanation.

Bolt Biotherapeutics presented positive results from animal trials of its lead drug, a tumor-targeting antibody connected to an immune stimulator.