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Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®


Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®
- For Use of Subcutaneous Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (D-VCd) in Newly Diagnosed Adult Patients with Systemic Light Chain (AL) Amyloidosis -
- For Use of Subcutaneous Daratumumab in Combination with Pomalidomide and Dexamethasone (D-Pd) in Adult Patients with Relapsed or Refractory Multiple Myeloma -
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SAN DIEGO, May 21, 2021 /PRNewswire/  Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Pharmaceutica N.V.  (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX ....

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Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma


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Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency
The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.
The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel. ....

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