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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Multiple Myeloma |
| Drug: | pomalidomide (TNFα inhibitor, IL-6 inhibitor, NK cell stimulant, IL-10 stimulant, IL-1β inhibitor) + Darzalex Faspro (daratumumab/hyaluronidase) (CD38 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Published date:
07/12/2021
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
Title:
Halozyme Announces Janssen Receives European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation for Newly Diagnosed Systemic Light-chain Amyloidosis and Pre-Treated Multiple Myeloma
Published date:
06/22/2021
Excerpt:
Halozyme Therapeutics...European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union...The second authorization is for the use of DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM)...
Source:
Title:
Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial
Published date:
06/01/2021
Excerpt:
...the daratumumab plus pomalidomide and dexamethasone group showed improved progression-free survival compared with the pomalidomide and dexamethasone group (median 12·4 months [95% CI 8·3–19·3] vs 6·9 months [5·5–9·3]; hazard ratio 0·63 [95% CI 0·47–0·85], two-sided p=0·0018)....Among patients with relapsed or refractory multiple myeloma, daratumumab plus pomalidomide and dexamethasone reduced the risk of disease progression or death versus pomalidomide and dexamethasone alone.
DOI:
https://doi.org/10.1016/S1470-2045(21)00128-5
Source:
Title:
Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX® (daratumumab) Subcutaneous (SC) Formulation for New Indications in Europe
Published date:
05/21/2021
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for DARZALEX...use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma (MM)...The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of MM is supported by data from the Phase 3 APOLLO study...
