Hyaluronidase

Johnson & Johnson seeks FDA and EMA approval for subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro) in high-risk smoldering multiple myeloma, supported by the AQUILA study. Initial AQUILA findings to be presented at the 2024 ASH Annual Meeting.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO® as monotherapy for high-risk smoldering multiple myeloma, aiming to treat before active disease onset.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO and DARZALEX SC, targeting high-risk smoldering multiple myeloma. AQUILA study (NCT03301220) investigates DARZALEX FASPRO versus active monitoring in 390 patients, focusing on progression-free survival. Smoldering multiple myeloma, an asymptomatic precursor to multiple myeloma, affects 15% of newly diagnosed cases, with half of high-risk patients progressing within two years. Multiple myeloma, a blood cancer affecting plasma cells, is the second most common blood cancer globally, with an estimated 35,000 new cases and 12,000 deaths in the U.S. in 2024.

Key trials at the 21st International Myeloma Society Annual Meeting, including CEPHEUS and AURIGA, showcased promising data on daratumumab combinations, CAR T-cell therapies, and bispecific antibodies, highlighting advancements in multiple myeloma treatment.

The CEPHEUS trial demonstrated that adding daratumumab and hyaluronidase-fihj (D-VRd) to standard bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved minimal residual disease (MRD)–negativity rates and complete response (CR) rates in transplant-ineligible or deferred newly diagnosed multiple myeloma patients. The study met its primary endpoint with 60.9% MRD-negativity in the D-VRd group vs 39.4% in the VRd group. The regimen also showed superior progression-free survival (PFS) and ongoing overall survival (OS) benefits, prompting a supplemental biologics license application to the FDA.

Johnson & Johnson submitted an FDA application for Darzalex Faspro-based D-VRd regimen to treat newly diagnosed multiple myeloma patients ineligible for transplant, based on CEPHEUS study results showing 60.9% MRD-negativity and 43% risk reduction for progression or death.

Subcutaneous daratumumab plus VRd showed higher MRD-negativity and CR rates vs VRd alone in transplant-ineligible multiple myeloma patients, with 60.9% vs 39.4% MRD-negativity and 81.2% vs 61.6% CR rates, suggesting potential as a new frontline regimen.

An sBLA for daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients was submitted to the FDA. Supported by phase 3 CEPHEUS trial data, D-VRd showed higher minimal residual disease (MRD)–negativity and complete response rates compared to VRd alone. If approved, D-VRd would be the first FDA-approved treatment based on MRD-negativity rate as a primary endpoint.

Johnson & Johnson submits sBLA to FDA for DARZALEX FASPRO® quadruplet regimen for newly diagnosed multiple myeloma patients, supported by CEPHEUS study showing 60.9% MRD-negativity and 43% reduced risk of progression or death.

The CEPHEUS trial showed that adding daratumumab to the VRd regimen improved MRD negativity rates to 60.9% vs 39.4% with VRd alone in newly diagnosed multiple myeloma patients ineligible for or deferred transplant, with a CR or better rate of 81.2% vs 61.6%. The subcutaneous daratumumab-based regimen demonstrated deep, durable responses and reduced disease progression risk, potentially becoming a new standard for this patient population.