FDA Approvals - Episode 8
Hello and welcome to OncLive News Network, Breaking News. I'm Gina Columbus.
The FDA has approved daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The frontline designation was based on findings from the ALCYONE study.
In the phase III study, daratumumab plus VMP elicited an 18-month progression-free survival rate of 71.6% versus 50.2% for VMP alone, representing a 50% reduction in the risk of progression or death. At a median follow-up of 16.5 months, follow-up for long-term survival remained ongoing.
In November 2016, the FDA approved daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.
For more breaking news, subscribe to email alerts from OncLive.com. Thank you for watching! I'm Gina Columbus.