J&J and Genmab’s drug races to second line treatment approval
pharmafile | November 22, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Genmab, Janssen, Johnson & Johnson, darzalex, multiple myeloma
Janssen, a part of Johnson & Johnson, and Genmab have announced that their multiple myeloma drug Darzalex (daratumumab) has been approved as a combination therapy for second-line treatment of bone marrow cancer. Janssen entered into a worldwide agreement to license and develop Darzalex back in 2012.
The drug Darzalex was trialled alongside Celgene’s Revlimid and Takeda’s Velcade, with the results being enough to convince the FDA to approve the combination therapy three months ahead of schedule.
The two Phase III trials, which together totalled over a 1,000 patients, reduced the risk of progression of the disease by an average of 62%. This was compared to the treatment with one of the aforementioned treatments alone, in patients with relapsed multiple myeloma following one prior therapy.
Multiple myeloma is an incurable blood cancer that begins in the bone marrow and is identified by an excess of plasma cells. IT is the third most common blood cancer in the US, with approximately 30,330 new patients diagnosed with the condition in 2016. Patients who relapse after treatment with standard therapies have few treatment options to extend their life. Darzalex then offers a promising treatment to those whose multiple myeloma has relapsed after one previous treatment, when there are few other options.
“This is an exciting day for patients with multiple myeloma in the U.S., who will now have the opportunity to receive Darzalex at an earlier point in treatment of their disease,” said Jan van de Winkel, chief executive officer of Genmab. “We believe daratumumab has the potential to become a backbone therapy for multiple myeloma.”
Genmab will be due a milestone payment of $65 million when J&J make their first commercial sale of the drug. The first sale is now expected to occur by the end of the year.
Ben Hargreaves
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