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TOP STORIES from the week

Innovent Biologics and Daiichi Sankyo Enter Exclusive Agreement for VANFLYTA® Commercialization in China

First Patient Dosed in Global Ph 3 Trial of BL-M14D1 in 1L Extensive-Stage SCLC

NMPA Accepts NDA for Sacituzumab Tirumotecan (sac-TMT) IN 1L TNBC

Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer

ACR-2316 advances into dose expansion portion of Ph 1/2 study in SCLC, squamous NSCLC, lung adenocarcinoma (adNSCLC), endometrial, cervical, and GEJ cancers

FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC

FDA Fast Track Designation for BI-1808 for the Treatment of Ovarian Cancer

TECVAYLI + TALVEY reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line R/R multiple myeloma

ACR-2316 advances into dose expansion portion of Ph 1/2 study in SCLC, squamous NSCLC, lung adenocarcinoma (adNSCLC), endometrial, cervical, and GEJ cancers

Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer

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Drug approvals

FDA grants Accelerated Approval to TUDRIQEV + Nivolumab combo for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

FDA approves Pluvicto for PSMA+ metastatic HSPC

Datroway approved in the EU for 1L metastatic TNBC patients not candidates for immunotherapy

Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1L advanced ER-positive breast cancer

Regulatory news

NMPA Accepts NDA for Sacituzumab Tirumotecan (sac-TMT) IN 1L TNBC

FDA Fast Track Designation for BI-1808 for the Treatment of Ovarian Cancer

CRL issued for ongoing ITM-11 NDA citing CMC and third-party commercial facility inspection-related items

FDA Clearance to Initiate Bria-PROS+ Clinical Study in Prostate Cancer

Trial results

Topline Results from Intranasal NEO100 in Recurrent IDH1-mutant High-grade Glioma to be presented

FAILED TRIAL: Ph 3 XPORT-EC-042 Trial of Selinexor in Endometrial Cancer Did Not Meet the Primary Endpoint of PFS improvement

MIRACLE R/R AML Trial Reports Positive Interim Data with 37% Blinded CRc in Venetoclax-Failed Patients

Positive Updated Ph 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma Announced 

trial status

First Patient Dosed in Global Ph 3 Trial of BL-M14D1 in 1L Extensive-Stage SCLC

ACR-2316 advances into dose expansion portion of Ph 1/2 study in SCLC, squamous NSCLC, lung adenocarcinoma (adNSCLC), endometrial, cervical, and GEJ cancers

First Patient Dosed in Ph 1 Study of DISP-10 in Advanced GI Cancers

Ph 1 Study of Neoadjuvant ELI-002 7P for Pancreatic Ductal Adenocarcinoma initiated

Business news

Innovent Biologics and Daiichi Sankyo Enter Exclusive Agreement for VANFLYTA® Commercialization in China

Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer

IMPACT Therapeutics Signs Exclusive License Agreement with Pharmanovia for Senaparib in Europe, Middle East and North Africa, Australia and New Zealand 

Amplia and Lilly to Evaluate Narmafotinib + Olomorasib in NSCLC

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