Approvals

Earlier in November, Johnson & Johnson Innovative Medicine have applied to the US Food and Drug Agency (FDA) and the European Medicines agency (EMA) for the approval of a new indication for DARZALEX FASPRO (daratumumab and hyluronidase-fihj). DARZALEX FASPRO would be used as a monotherapy for the treatment of high-risk smouldering multiple myeloma in adult patients.

If approved, DARZALEX would be the first treatment for high-risk myeloma patients. According to the press release, smouldering multiple myeloma is an early precursor of active multiple myeloma, where abnormal cells can be detected in the bone marrow, but patients are typically asymptomatic.

The decision for the approval would be based on the data from the AQUILA study, which is a multicentre randomised phase 3 study with the aim of investigating the effects of DARZALEX versus no treatment for patients with high-risk smouldering myeloma. The results from this study will be publicly disclosed at the 2024 American Society of Hematology (ASH) annual meeting in December later this year.

DARZALEX FASPRO received FDA approval in 2020 for the treatment of five indications in multiple myeloma patients, including those with a new diagnosis, relapsed patients, patients who are ineligible for a transplant and refractory patients.

Yusri Elsayed MD, MHSc, PhD global therapeutic area head, Oncology, Innovative Medicine, Johnson & Johnson stated, “There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smouldering multiple myeloma at high-risk of progressing to active multiple myeloma. DARZALEX has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smouldering multiple myeloma, potentially shifting the treatment paradigm.”