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J&J Files Application for Darzalex Label Expansion With FDA

Zacks Equity Research

Johnson & Johnson’s JNJ subsidiary, Janssen, announced that it has submitted a supplemental biologics license application (sBLA) to the FDA for the label expansion of its multiple myeloma drug, Darzalex (daratumumab). The sBLA is seeking label expansion of Darzalex in combination with Amgen’s AMGN Kyprolis (carfilzomib) and dexamethasone as second to fourth-line treatment option for patients with relapsed/refractory multiple myeloma (r/rMM).

Darazalex is already marketed in the United States as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The drug is already approved in several combination regimens for the treatment of different multiple myeloma indications as well as in different treatment settings.

The sBLA was supported by data from the phase III CANDOR study. In the study, treatment with the three-drug Darzalex combo (DKd) led to a reduction in the risk of progression or death by 37% in patients with r/rMM.

The randomized, open-label CANDOR study was initiated by Amgen as part of its collaboration agreement with Janssenwhich is also co-funding the study along with Amgen.

Shares of J&J have gained 13.2% in the past year compared with the industry’s increase of 12.5%.

Currently, Darzalex is approved for only intravenous administration. Meanwhile, J&J has developed a subcutaneous formulation of Darzalex using Halozyme’s HALO ENHANZE drug delivery technology. The company submitted a BLA in July last year seeking approval for the new formulation of Darzalex. A potential approval to subcutaneous formulation may boost sales of the drug as it is likely to make administration of the drug easier.

Darzalex is a key drug in J&J’s portfolio. Sales of the drug rose 48% year over year to $3 billion in 2019.

Meanwhile, Darzalex is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings. These include combination studies with other cancer drugs like Roche Holding AG’s RHHBY Tecentriq and Bristol-Myers’ Opdivo.

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J&J currently carries a Zacks Rank #3 (Hold).

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