Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs […]Read More
Shots: The accelerated approval is based on KEYNOTE-158 study assessing Keytruda (200mg, q3w). In a study, 1,050 patients were included in the efficacy analysis population in which TMB was analyzed in the subset of 790 patients with sufficient tissue for testing based on protocol-specified testing requirements, out of 790, 102 had tumors identified as TMB-H, […]Read More
Shots: The US FDA has approved Tecentriq (atezolizumab) as a 1L Treatment for adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations […]Read More
Shots: The approval is based on P-III PRIMA study assessing Zejula (300/200mg, qd) vs PBO in patients with newly diagnosed advanced ovarian cancer following complete or partial response to platinum-based CT regardless of biomarker status The P-III PRIMA study resulted in a 57% improvement in PFS in HRd population and a 38% reduction in the […]Read More
Shots: The sBLA submission is based on P-III IMpower110 study assessing Tecentriq as monothx. vs CT in 572 PD-L1-selected (TC3/IC3-WT), CT-naïve patients with advanced sq. or non-sq. NSCLC without ALK or EGFR mutations The P-III Impower110 study results: improvement in OS by 7.1mos. (20.2 vs 13.1mos.), the safety profile is consistent with its known safety […]Read More
Shots: The approval is based on P-III ADMIRAL study assessing Gilteritinib as monothx. vs salvage CT In patients with relapsed or refractory FLT3mut+ AML. The approval follows EMA’s accelerated assessment and ODD which reduced the timeframe for approval The P-III ADMIRAL study resulted in longer OS i.e, mOS (9.3 vs 5.6mos.); rates of one-year survival […]Read More
Shots: The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC who were not candidates for surgical resection/definitive chemoradiation/mNSCLC with PD-L1 expression & no prior systemic treatment for mNSCLC including data from the extension of KEYNOTE-042 in Chinese patients The extension study results […]Read More
Shots: The approval is based on two studies, KEYNOTE-181 study results involve assessing of Keytruda (200mg, q3w) vs CT (paclitaxel/docetaxel) in 628 patients in a ratio (1:1) with 1L+ LA/m- EC with disease progression. The KEYNOTE-180 study results involve assessing of Keytruda in 121 patients with 1L+ LA/m- EC with disease progression KEYNOTE-181 results: In […]Read More
Shots: The approval is based on KEYNOTE-158 & KEYNOTE-028 studies result assessing Keytruda (200mg, IV) in patients with SCLC with disease progression on/after platinum-based CT, prior treated with 1L+ therapy Collective results: ORR (19%); CRR (2%); PRR (17%); DOR @6mos. (94%); DOR @12mos. (63%); DOR @18mos. (56%) Keytruda is an anti-PD-1 therapy, blocking the interaction […]Read More
Shots: The approval is based on P-III KEYNOTE-042 trial results assessing Keytruda (200mg, q3w) vs CT in 1274 patients in ratio (1:1) with 1L stage III whose tumors expressed PD-L1 with TPS ≥1% and who had not received prior systemic treatment for metastatic NSCLC P-III KEYNOTE-042 study results: @ TPS ≥1%, TPS ≥50% mOS (16.7, […]Read More
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