Tags : Multiple Myeloma

Regulatory

Janssen Initiates Rolling Submission of BLA to US FDA of

Shots: Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to […]Read More

Regulatory

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment

Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT) Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in […]Read More

Clinical Trials Pharma

Janssen Collaborates with SpringWorks to Evaluate Nirogacestat + Teclistamab for

Shots: The companies will evaluate SpringWorks’ Nirogacestat (GSI) in combination with Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with r/r MM. The companies anticipate commencing the study by early 2021 Janssen to sponsor and conduct a P-I study assessing the safety, tolerability, and preliminary efficacy of the combination, and will assume all costs […]Read More

Clinical Trials

Takeda Reports Results of Ninlaro (ixazomib) in a P-III Clinical

Shots: The P-III TOURMALINE-MM2 involves assessing of Ninlaro (ixazomib) + lenalidomide and dexamethasone vs PBO + lenalidomide and dexamethasone in 705 adult patients with newly diagnosed MM patients not eligible for autologous stem cell transplant Results: 13.5mos. increase in m-PFS (35.3 vs 21.8mos.); trial did not meet the threshold for statistical significance and 1Eps of […]Read More

Biotech Regulatory

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the

Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile […]Read More