J&J Files Application For Darzalex Label Expansion With FDA
Zacks Investment Research | Feb 10, 2020 09:15PM ET
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.
Johnson & Johnson Price
Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.