J&J Submits Regulatory Applications for Subcutaneous Darzalex in Combination with Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma

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On the 12th, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that it had submitted regulatory applications to the U.S. FDA and the European EMA, respectively, seeking approval for the subcutaneous (SC) formulation of Darzalex (daratumumab), in combination with pomalidomide and dexamethasone (the D-Pd regimen), for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least one prior therapy. In the United States and the European Union, the SC formulation of Darzalex is marketed under the brand names Darzalex Faspro (daratumumab and hyaluronidase-fihj) and Darzalex SC, respectively.

As a fixed-dose formulation, Darzalex Faspro/Darzalex SC has an administration time of approximately 3–5 minutes, which is significantly shorter than that of the intravenous (IV) formulation, typically requiring several hours.

In 2017, the D-Pd regimen received approval from the U.S. FDA for the use of Darzalex IV formulation in patients with relapsed/refractory multiple myeloma (r/r MM) who had previously received at least two prior therapies, including lenalidomide and a proteasome inhibitor. This formulation of the D-Pd regimen has not yet been approved by the European Medicines Agency (EMA).

Image source: darzalex.com

This application is supported by the positive results from the Phase 3 APOLLO study (MMY3013). This was a multicenter, randomized, open-label study conducted in patients with relapsed/refractory multiple myeloma (r/r MM) who had received at least one prior therapy, had been treated with lenalidomide and a proteasome inhibitor, and had confirmed disease progression. The study compared the Darzalex Faspro/Darzalex SC + pomalidomide + dexamethasone regimen (D-Pd) with the pomalidomide + dexamethasone regimen (Pd).

The results showed that the study met its primary endpoint: progression-free survival (PFS) was significantly improved in the D-Pd treatment group compared with the Pd treatment group. The full results of the study will be presented orally at the American Society of Hematology (ASH) Annual Meeting on December 6.

The active pharmaceutical ingredient of Darzalex is daratumumab, a monoclonal antibody targeting CD38. The drug was first approved in the United States in 2015 and in the European Union in 2016 as a monotherapy for the treatment of multiple myeloma (MM), making it the first anti-CD38 monoclonal antibody approved globally for the treatment of MM. In 2020, Darzalex Faspro/Darzalex SC became the only CD38-targeting antibody approved by the U.S. FDA and the European EMA for subcutaneous administration in the treatment of patients with MM.

Darzalex Faspro/Darzalex SC was developed using Halozyme’s ENHANZE drug delivery technology and contains recombinant human hyaluronidase PH20 (rHuPH20) in its formulation. As of 2020, Darzalex had been approved by regulatory authorities worldwide for six combination regimens, as well as for use as monotherapy in patients with newly diagnosed, relapsed, or refractory multiple myeloma (MM).

In China, Darzalex was approved in October 2019 as a monotherapy for the treatment of patients with relapsed and refractory multiple myeloma (MM). As the first CD38-targeted monoclonal antibody approved in China, this innovative regimen is poised to redefine the treatment landscape for MM in the country.

References:

J&J files applications for subcutaneous Darzalex in multiple myeloma