Tags : hyaluronidase-fihj

Janssen Reports sBLA Submission to the US FDA for Darzalex

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 […]Read More

Genmab and Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receive the

Shots: The approval is based on two studies: COLUMBA (MMY3012, P-III) study and P-II PLEIADES (MMY2040) study, which involves assessing of subcutaneous daratumumab (1800 mg) with rHuPH20 2,000 U/mL, combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP) In Feb 2019, results from COLUMBA study were announced, presented in oral […]Read More