J&J's Darzalex Subcutaneous Version Gets Approval in Europe
Janssen, a subsidiary of Johnson & Johnson JNJ, announced that the European Commission has granted marketing authorization for the subcutaneous (“SC”) formulation of blood cancer drug, Darzalex (daratumumab) as a treatment for multiple myeloma (MM).
The approval applies to all current MM indications of Darzalex in frontline and relapsed/refractory settings. Patients currently on Darzalex intravenous formulation (“IV”) can switch to the SC formulation.
With the approval to the SC formulation of Darzalex, the administration time will be significantly reduced to three to five minutes compared to hours for IV formulation.
The SC formulation of Darzalex was approved by the FDA last month for similar indications, which is available as Darzalex Faspro. The SC formulation is developed using Halozyme’s HALO ENHANZE technology.
Please note that an intravenous formulation of Darzalex is approved as monotherapy as well as in combination with other drugs for treating MM patients in first-line as well as second or later-line settings.
The approval for subcutaneous formulation was based on data from the phase III COLUMBA study as well as phase II PLEIADES study. Data from both studies have shown that Darzalex SC had consistent overall response rate and a similar safety profile compared to Darzalex IV in patients with relapsed or refractory MM.
Shares of J&J have increased 0.6% year to date against the industry’s decline of 1.6%.
Darzalex is a key drug in J&J’s portfolio. Sales of the drug rose 49% to $937 million in the first quarter of 2020. In the United States, market growth and market share gains drove sales. Outside U.S. markets, increased penetration and share gains boosted sales.
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, Bristol-Myers’ BMY Opdivo and Amgen’s Kyprolis.
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