DARZALEX® (daratumumab) receives positive CHMP opinion for patients with high-risk smouldering multiple myeloma
“The positive recommendation from the CHMP marks an important step towards addressing the needs of people living with high-risk smouldering multiple myeloma,” said Ester in’t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “Early disease intervention with daratumumab has the potential to reduce the risk of progression to active multiple myeloma or death by 51 percent for patients with high-risk disease. Pending European Commission approval, patients and physicians will have an option to treat high-risk smouldering multiple myeloma, with the aim to intercept this complex blood cancer before it develops into active disease and importantly, before end-organ damage occurs.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000