Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM The study demonstrated that the combination regimen demonstrated a reduction […]Read More
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
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