AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots:The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regionsOpinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi Rastogi4 days ago

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AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots:AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapyImfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

ByRidhi RastogiMay 12, 2025

TOP 20

Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

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Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:Health Canada has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRTApproval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi (for ~24mos.) vs PBOStudy showed reduced risk…

ByRidhi RastogiApril 11, 2025

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AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Shots:The EC has approved perioperative Imfinzi regimen to treat resectable NSCLC adults at high risk of recurrence & no EGFR mutations or ALK rearrangements; MAA under PMDA reviewApproval was based on P-III (AEGEAN) trial assessing neoadj. Imfinzi (1500mg; Q3W × 4 cycles) + CT followed by adj. Imfinzi alone (Q4W × ~12 cycles)…

ByRidhi RastogiApril 4, 2025

News

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

ByRidhi RastogiMarch 17, 2025

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AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots:AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…

ByRidhi RastogiMarch 7, 2025

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AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

Shots:The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063)…

ByRidhi RastogiFebruary 17, 2025

News

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…

ByRidhi RastogiFebruary 6, 2025

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Shots:The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industryIn October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…

BySenior EditorNovember 23, 2023

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Top 20 Biopharma Companies of 2025

Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Insights+: EMA Marketing Authorization of New Drugs in October 2023

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