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