Genmab, J&J score another quickie Darzalex approval

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The FDA has again ruled favorably on Darzalex ahead of schedule.

The FDA has approved a label expansion for Genmab and Johnson & Johnson’s multiple myeloma drug Darzalex three months ahead of schedule. The nod clears J&J to market Darzalex in combination with Celgene’s Revlimid or Takeda’s Velcade as a second-line treatment for the bone marrow cancer.

J&J bagged breakthrough status in the indication in July, filed for approval in August and received confirmation that the FDA would prioritize the review last month. That set the partners up to hear from the FDA by mid-February, but the agency has used a fraction of the time available to it to make its decision. The FDA acted similarly swiftly when it originally approved Darzalex last year. The earlier decision took the FDA two months.

The speed at which the FDA has acted reflects the strength of the data put together by J&J and Genmab. J&J’s submission for second-line use in combination with Celgene and Takeda’s drugs was based on the Castor and Pollux phase 3 trials, the results from which wowed attendees at cancer conferences earlier this year.


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Having secured the approval ahead of schedule, Genmab now expects the first commercial sales of Darzalex in combination with Revlimid or Velcade to happen before the end of the year. When J&J makes the sale, it will trigger a $65 million (€61 million) milestone payment to Genmab. The payout continues the succession of milestones received by the Danish drugmaker as Darzalex has advanced. Investors have responded by driving up the share price of Genmab by 360% in two years.

The optimism of investors is underpinned by a belief that Darzalex will quickly establish itself as a cornerstone of clinicians’ go-to second-line treatment regimens and the hope that, over time, the drug can muscle in on several other use cases, including first-line treatment, maintenance therapy and management of asymptomatic “smoldering” multiple myeloma.

Work to continue expanding use of Darzalex is underway. A PDUFA date for the drug in combination with Celgene’s Imnovid is scheduled for June. And additional data on a subcutaneous formulation of Darzalex are due next month. That formulation, a phase 3 trial that could start next year, would significantly shorten infusion times.

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