FDA ODAC votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma
“Early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death,” said Sen Zhuang, M.D., Vice President, Oncology Clinical Research, Johnson & Johnson Innovative Medicine. “The proactive approach demonstrated in the AQUILA study is an example of Johnson & Johnson’s aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease.”
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“This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology,” said Josh Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. “We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies
AIM Chief Executive Officer Thomas K. Equels stated: “AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most
“We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “The study did not meet its primary endpoint, but the results from TRIDENT
“Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a