Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) to Treat Patients with Light Chain (AL) Amyloidosis

 Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) to Treat Patients with Light Chain (AL) Amyloidosis

Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) to Treat Patients with Light Chain (AL) Amyloidosis

Shots:

  • The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis
  • The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and reviewed under Project Orbis
  • Darzalex Faspro is approved as the only SC CD38-directed Ab for MM and is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) and Halozyme’s ENHANZE drug delivery technology

Click here ­to­ read full press release/ article | Ref: Janssen | Image: RTV

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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