Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who have received 1 to 3 prior lines of therapy across 69 centers spanning 16 countries The addition of Kd in Sarclisa leads to a 47% reduction in the risk of […]Read More
Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 10^6 CAR T cells over a range of 260 to 500 x 10^6 CAR-positive viable T cells) in 128 patients with r/r MM prior treated with 3L therapies including an immunomodulatory agent, a proteasome inhibitor & an […]Read More
Shots: The US FDA has granted ODD to CFT7455 for the treatment of MM. The FDA grants ODD to drugs & biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the US In Jun’21, the company has initiated a […]Read More
Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with RRMM who have received at least one prior treatment regimen including lenalidomide & a proteasome inhibitor The study met its 1EPs of PFS & showed 37% reduction in risk of […]Read More
Shots: The approval is based on P-III trial evaluating efficacy & safety of Kyprolis + dexamethasone in 123 patients with RRMM who have received at least 2 prior therapies, including a proteasome inhibitor & an immunomodulatory agent Results: ORR (35.8%); m-PFS (5.6mos.) as assessed by IRC. Additionally, results showed that the efficacy & safety in […]Read More
Shots: Eureka and MSK are eligible to receive up front and ~$1B as development, regulatory and sales milestone along with royalties on net sales. Sanofi gets exclusive rights to the GPRC5D binder for non-CAR use Eureka discovered the GPRC5D binding domain using its E-ALPHA Abs discovery platform, under its collaboration with MSK Additionally, targeting GPRC5D […]Read More
Shots: AbbVie exercised its exclusive right to acquire TeneoOne and its TNB-383B based on an interim analysis of an ongoing P-I study that demonstrated ORR (79%), VGPR (63%), CR (29%) at doses ≥40 mg in the dose-escalation cohorts with a median follow-up time of 6.1 mos., m-DOR has not been reached In Feb’2019, AbbVie and […]Read More
Shots: The P-III MAIA study assessing Darzalex + lenalidomide & dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with MM ineligible for high-dose CT & ASCT MAIA longer-term follow-up analysis showed i.e @5yrs., OS rate (66% vs 53%), PFS rate (53% vs 29%), ORR (93% vs 82%) & median time to next […]Read More
Shots: The FDA’s BT and EMA’s PRIME designations are based on data from the P-I MajesTEC-1 study evaluating the safety and efficacy of teclistamab (Ab targeting BCMA and CD3) in adults with r/rMM. The findings will be presented at ASCO 2021 In preclinical studies, the therapy kills myeloma cell lines and bone marrow-derived myeloma cells […]Read More
Shots: The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least 3 prior line therapies across the US, EU, China, and Japan The 1EP of the P-Ib study is to characterize the safety and confirm the dose of the therapy while the primary objective of […]Read More
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