J&J Seeks Darzalex's Label Expansion In First-Line Setting

Johnson & Johnson (NYSE:JNJ) announced the submission of regulatory applications to the FDA and the European Medicines Agency ("EMA") seeking label expansion of its multiple myeloma (“MM”) drug Darzalex in the first-line setting.

A potential approval will allow Darzalex to be used in combination with J&J’s proteasome inhibitor MM drug Velcade (bortezomib), melphalan and prednisone to treat MM in treatment-naïve patients who cannot have autologous stem cell transplantation in bone marrow. If approved, this will be the fifth indication for the drug.

We are encouraged by J&J’s efforts to expand Darzalex’s label further, a drug which generated one-sixth of the company’s total oncology sales in the first nine months of 2017. We note that Darzalex was first approved in November 2015 as monotherapy for MM in patients treated with at least three prior lines of therapy, followed by approvals in the past two years as combination therapy in second and third-line settings.

J&J’s shares have outperformed the industry so far this year. The company’s shares have gained 20.1% compared with the industry’s gain of 14.8%.

J&J has submitted top-line data from the phase III ALCYONE study to support its regulatory applications in both the geographies. Data from the study showed that the Darzalex combination therapy reduced the risk of disease progression or death by 50% when compared to treatment with bortezomib, melphalan and prednisone (standard of care) alone.

J&J will present the data at the Annual Meeting of the American Society of Hematology scheduled to be held between Dec 9 and Dec 12.

We note that J&J licensed Darzalex from Genmab through its subsidiary, Janssen, in 2012. J&J holds the worldwide rights to develop, manufacture and commercialize the drug and has to pay milestone payments to Genmab.

Per the National Cancer Institute, 30,280 new patients are likely to be diagnosed with MM and it will cause 12,590 deaths in the United States in 2017 alone.

Darzalex competes with other approved and marketed treatments for MM, which include Celgene Corporation’s (NASDAQ:CELG) Revlimid, Amgen Inc.’s (NASDAQ:AMGN) Kyprolis and Bristol-Myers’ (NYSE:BMY) Emplicti.

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J&J carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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