J&J Files Application For Darzalex Label Expansion With FDA

Johnson & Johnson’s (NYSE: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 (NASDAQ: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 (NASDAQ: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 (SIX:ROG) AG’s (OTC:RHHBY) Tecentriq and Bristol-Myers’ Opdivo.

Zacks Rank

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

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

Zacks Top 10 Stocks for 2020

In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?

Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.

Access Zacks Top 10 Stocks for 2020 today >>