J&J files to expand Darzalex label, triggering another payout to Genmab

FDA sign

Johnson & Johnson ($JNJ) and Genmab (CPH:GEN) have passed another milestone on the route to FDA approval of Darzalex as a second-line combination treatment for multiple myeloma. The latest step forward is the filing of an sBLA with FDA, an event that, if the regulator responds as quickly as in the past, could lead to the partners winning approval before the end of the year.

J&J has asked the FDA to handle Darzalex as a priority review, a status it could be eligible for under the terms of its breakthrough therapy designation. If the FDA accepts the request, it will process the sBLA within 6 months of now, setting J&J and Genmab up to receive a decision by mid-February. History suggests a decision could arrive well before then, though. When J&J sought approval in heavily pretreated or double refractory multiple myeloma patients late last year, the FDA made its decision in two months.

Approval of the sBLA would clear J&J to market Darzalex toward a larger proportion of multiple myeloma patients. The current approval makes Darzalex a near last resort option for patients who have already tried multiple other drugs. That could change soon. The sBLA positions Darzalex, a CD38 monoclonal antibody, to be used in combination with Celgene’s ($CELG) Revlimid or Takeda’s Velcade in multiple myeloma patients who have been through one other line of treatment.

The data in support of the use of the combinations in these patients are compelling. J&J and Genmab unveiled the results at cancer conferences earlier this year, at which time the Danish drugmaker’s stock spiraled upward in anticipation of the paydays the data would lead to. Another one of those paydays arrived with the sBLA filing, an event that triggered a $15 million (€13 million) milestone payment to Genmab.

As well as data from the Phase III Revlimid and Velcade combination trials, J&J included results from a Phase I study in the sBLA. The Phase I trial gave Darzalex in combination with Celgene’s Pomalyst, an immunomodulator. Data from the trial, which were presented late last year, have been somewhat overshadowed by the subsequent release of the Phase III results. But the potential of the combination has caught the attention of some physicians.

Speaking to OncLive, Dr. Sagar Lonial, an Emory University School of Medicine professor who has been involved in trialling Darzalex, said: “The data ... was really pretty striking. What I think it really does is speak to the concept of non-cross-reactive drugs working synergistically.”

Given in isolation to refractory multiple myeloma patients, Darzalex and Pomalyst achieve response rates of approximately 30%. The Phase Ib combination trial achieved a response rate of approximately 70%, a fact that Lonial sees as showing the drugs complement each other.

“It really speaks to synergy between an antibody and an immunomodulatory agent ... that seems to not only directly target myeloma, but enhance [the] immune system's ability to make [Darzalex] a better drug,” he said.

- read the release
- view the OncLive video

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