Janssen Reports Submission of BLA to the US FDA for Darzalex (daratumumab) Subcutaneous Formulation for Multiple Myeloma
Janssen’s Sirturo (bedaquiline) Receives FDA’s Accelerated Approval as a Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis
Shots:
- The BLA submission is based on P-III COLUMBA & P-II PLEIADES studies. P-III COLUMBA study involves assessing Darzalex SC vs Darzalex IV in 522 patients with MM prior treated with 3L therapies. The P-II PLEIADES study involves assessing of Darzalex SC + D-VRd/D-VMP in 240 patients with r/r multiple myeloma
- The BLA submission follows approval of Darzalex in combination with lenalidomide and dexamethasone based on P-III MAIA study & PR designation following sBLA supported by P-III CASSIOPEIA study
- Darzalex is a CD38-directed antibody and is an approved therapy as monothx. or in combination with other drugs in multiple countries including the US for the treatment of multiple myeloma. In Aug’2012, Genmab granted exclusive rights of Darzalex to Janssen
Click here to read full press release/ article | Ref: Janssen | Image: PMLiVE