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
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
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
Shots: The approval is based on a pivotal study, DREAMM-2 assessing Blenrep (2.5 mg/kg, q3w) in 218 patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current SoC Results: Blenrep demonstrated an ORR (31%), DoR not reached at the 6-mos. analysis, but 73% of responders had a DoR […]Read More
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
Shots: The US FDA’s ODAC has voted 12-0 in favor of the demonstrated benefit of belantamab mafodotin monothx. outweighing the risks for patients with r/r MM prior treated with at least four therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Two committee members could not participate in the final vote The […]Read More
Shots: EC’s approval is based on P-III ICARIA-MM study assessing Sarclisa + (pomalidomide and dexamethasone) pom-dex vs pom-dex as monothx. for patients with r/r MM, prior treated with at least two therapies including lenalidomide and a proteasome inhibitor with progression on the last therapy Results: mPFS (11.53 vs 6.47mos.); OS (60.4% vs 35.3%); In an […]Read More
Shots: The P-Ib/II CARTITUDE-1 study involves assessing JNJ-4528 in 29 heavily pretreated patients with r/r MM. The P-Ib results will be shared at ASCO The P-Ib/II study results: 100% ORR with 97% good PR and 3% PR; patients achieving stringent CR @median of 11.5mos (86%), PFS at 9mos (86%); median time to first response was […]Read More
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
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
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