Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

 Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Shots:

  • The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis
  • Genmab to receive $30M as milestones with the first commercial sale of Darzales faspro in this indication. The US FDA reviewed the submission of data for approval in this indication under RTOR pilot program and Project Orbis
  • Darzalex faspro is the SC formulation of daratumumab and is the only therapy for newly diagnosed Light-chain (AL) amyloidosis in the US

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Medwatch

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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