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

News

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

Shots:The EC has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts who have received endocrine therapy & ≥1L of CT in the advanced settingApproval was based on global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin,…

ByDipanshu DixitApril 10, 2025

News

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

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots:The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regionsTrial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

News

AstraZeneca Reports the Data from PURSUIT P-IIb Study Evaluating AZD0780

Shots:AstraZeneca presented data at the ACC'25 and simultaneously published data in JACC from the PURSUIT P-IIb study (n=480) evaluating the efficacy, safety, and tolerability of AZD0780 (1mg, 3mg, 10mg & 30mg QD) added to SoC statin therapy vs PBO in dyslipidemic patients with LDL-C levels ≥70 and <190 mg/dL on moderate or high intensity…

ByRidhi RastogiApril 1, 2025

News

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL)

Shots:The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regionsOpinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…

ByRidhi RastogiMarch 31, 2025

News

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots:Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…

ByRidhi RastogiMarch 28, 2025

News

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Shots:AstraZeneca to present Tagrisso’s data from P-III (LAURA & FLAURA2) & P-II (SAVANNAH & ORCHARD) trials at ELCC 2025 for EGFRm NSCLC pts who failed or received 1L therapy; data to support global filingsIn LAURA, Tagrisso showed favorable OS trend (mOS: 58.8 vs 54.1mos.; maturity: 31%) despite 78% of PBO pts receiving it…

ByRidhi RastogiMarch 25, 2025

News

AstraZeneca to acquire EsoBiotec for ~$1B

Shots:AstraZeneca to acquire EsoBiotec, which will operate as AstraZeneca’s subsidiary, while maintaining its operations in Belgium to advance cell therapy As per the deal, AstraZeneca will acquire all outstanding equity of EsoBiotec on a cash & debt-free basis for ~$1B, incl. $425M upfront at closing & ~$575M in development & regulatory milestones; closing…

ByRidhi RastogiMarch 18, 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

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

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

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

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

AstraZeneca Reports the Data from PURSUIT P-IIb Study Evaluating AZD0780

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL)

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

AstraZeneca to acquire EsoBiotec for ~$1B

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

Contact US

OUR INFORMATION

FOLLW US

FOLLW US

Sign Up to Our Newsletter