Tags : Multiple Myeloma

BMS and bluebird bio Report the US FDA’s Acceptance of

Shots: The US FDA has accepted the PR of BLA for idecabtagene vicleucel to treat adult patients with MM prior treated with at least three therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab. The anticipated PDUFA date is Mar 27, 2021 The BLA is based on a P-II KarMMa study assessing […]Read More

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

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

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

BMS and bluebird bio to Resubmit the BLA for Idecabtagene

Shots: Shots: The companies receive the US FDA’s Refusal to File letter regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated r/r MM, which was submitted in Mar’2020 Upon preliminary review, the US FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review Ide-cel […]Read More

Sanofi Reports Results of Sarclisa (isatuximab) in P-III IKEMA trial

Shots: The P-III trial involves assesing of Sarclisa (IV, 10mg/kg qw for four weeks) in combination with carfilzomib (20/56mg/m2, bid) and dexamethasone in 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries The study resulted in meeting its 1EP and resulted in the reduction of risk of disease progression or death with […]Read More