The FDA has granted Janssen’s breakthrough myeloma drug priority review for patients who have received three or more prior therapies.
Daratumumab, which was granted Breakthrough Therapy Designation in May 2013, joins the ranks of Bristol-Myers Squibb and AbbVie’s myeloma drug elotuzumab, which also received priority review last week.
The decision was based on data from the phase II MMY2002 (Sirius) trial in which daratumumab showed a 65% one-year overall survival rate and nearly 30% objective response rate in patients with double refractory multiple myeloma.
Craig Tendler, VP at Janssen, said: “Daratumumab has the potential to be the first anti-CD38 monoclonal antibody approved to treat myeloma, offering these patients an important new treatment pathway.”
In addition to results from the Sirius trial, the application also included data from four other studies, including the phase I/II GEN501 in which median progression free survival rates were 5.6 months and the one-year survival rate was 77%.
When the findings on daratumumab were first released in May this year, Henk Lokhorst of the department of haematology at VU University Medical Centre, Amsterdam, said: “What is impressive about this study is that daratumumab monotherapy induced durable responses that improved or deepened over time, and 65% of responding patients remained in remission at 12 months.
“These findings speak to the potential of daratumumab as an option for patients with multiple myeloma who no longer respond to existing therapies.”
Janssen entered into a deal with Danish firm Genmab A/S in August 2012 that granted Janssen exclusive license to develop, manufacture and commercialise daratumumab.
The market for myeloma is quickly becoming increasingly competitive, as there are a number of drugs set to enter, or already entering, the market, such as Takeda’s ixazomib and Novartis’ recently-approved HDAC inhibitor Farydak (panobinostat).
Analysts have predicted the myeloma treatment market value will expand from $7.3bn in 2014 to just under $9bn by 2021.