Janssen Korea said Monday its treatment for multiple myeloma, DARZALEX (daratumumab), gained government approval last week with trials proving the drug to extend median overall survival of cancer patients by around a year.
DARZALEX can now be used as a monotherapy for relapsed or refractory multiple myeloma (MM) patients who had treatment with at least three other therapies, including proteasome inhibitors and immunomodulatory agents, the company said.
“Most MM patients experience relapse, so they need newer treatment options,” said Professor Lee Je-jung, chairman of the Korean Multiple Myeloma Working Party. “In Korea, there is no available option for relapsed or refractory multiple myeloma patients who failed treatment with pomalidomide, so DARZALEX is expected to change the MM treatment paradigm.”
The approval is based on SIRIUS results – a phase 2 trial that showed the drug to be effective and safe in patients whose cancer relapsed, the company said.
Median overall survival was significantly higher in the DARZALEX arm than in the control arm (17.5 months vs. 5.1 months), the results showed. The drug was also well tolerated with no severe infusion-related reactions, the company said.
"Janssen Korea remains committed to improving the quality of life and extending survival for patients with multiple myeloma in Korea with Velcade and DARZALEX,” said Kim Oak-yeon, managing director of Janssen Korea.
Multiple myeloma is a blood cancer that affects about 6,500 people in Korea with more than 80 percent of patients over the age of 50. Most patients experience a relapse or resistance to existing treatments with the average survival rate for these patients being about 5.1 months, the company said.
<© Korea Biomedical Review, All rights reserved.>