Multiple myeloma
Oncology· 15 reviewed drugs· 11987 cited findings behind them
What the regulatory reviews cover
This library contains regulatory review documents for several drugs indicated for multiple myeloma. These include Talvey, Pepaxti, Abecma, Nexpovio, Velcade, Carvykti, Lynozyfic, Sarclisa, Elrexfio, Tecvayli, Ninlaro, Darzalex, Farydak, Empliciti, and Zolsketil pegylated liposomal.
Different drugs were studied in different trials, so figures are not head-to-head. For example, Talvey showed an Overall Response Rate (ORR) for the 0.4 mg/kg weekly regimen of 73%. Abecma demonstrated an Overall response rate (ORR) in Study CRB-401 of 86%. Pepaxti reported a median PFS (melflufen + dex) of 6.83 months compared to a median PFS (pom + dex) of 4.93 months. Ninlaro's PFS (ixazomib arm, 1st interim analysis) was 20.6 months, while the PFS (placebo arm, 1st interim analysis) was 14.7 months.
The drugs — one cited result each
| Talvey Johnson & Johnson | Overall Response Rate (ORR) for 0.4 mg/kg weekly regimen: 73% Johnson & Johnson — Talvey FDA Review, p.27 |
| Pepaxti Oncopeptides | median PFS (melflufen + dex): 6.83 months Oncopeptides — Pepaxti EMA EPAR public assessment report (EM, p.99 |
| Abecma Bristol-Myers Squibb Company | Overall response rate (ORR) in Study CRB-401: 86% Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.8 |
| Nexpovio Stemline B V | Overall response rate (ORR): 25.3 Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.14 |
| Velcade Johnson & Johnson | Overall Response Rate (CR+PR) after 4 cycles (SC): 43 TAKEDA PHARMS USA — Velcade FDA Review, p.70 |
| Carvykti Johnson & Johnson | Overall Response Rate (ORR): 87.8% Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.7 |
| Lynozyfic Regeneron Pharmaceuticals, Inc. | Overall Response Rate (ORR): 71% Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.14 |
| Sarclisa Sanofi | ORR in TCD14079 Part B: 53.2 Sanofi — Sarclisa EMA EPAR public assessment report (EMEA/H/, p.60 |
| Elrexfio Pfizer Inc. | Overall Response Rate (ORR) by BICR: 75 (61.0) % Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.122 |
| Tecvayli Johnson & Johnson | Overall Response Rate (ORR): 62.0 Tecvayli EMA EPAR public assessment report (EM, p.69 |
| Ninlaro Takeda Pharmaceutical Company Limited | PFS (ixazomib arm, 1st interim analysis): 20.6 TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.8 |
| Darzalex Johnson & Johnson | Overall Response Rate (ORR) in MMY2002: 29% JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 76103, p.10 |
| Farydak Secura Bio | Median PFS (investigator-assessed) in panobinostat + BD arm: 12.0 SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7 |
| Empliciti Bristol-Myers Squibb Company | PFS Hazard Ratio: 0.70 BRISTOL MYERS SQUIBB — Empliciti FDA Summary Review (NDA/BLA, p.5 |
| Zolsketil pegylated liposomal Accord S L U | CHMP positive opinion date: 24 March 2022 Accord S L U — Zolsketil pegylated liposomal EMA EPAR public, p.9 |
Different drugs were studied in different trials — these figures are not head-to-head comparisons.
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Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only — not medical or investment advice.