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TOP STORIES from the week

First patient dosed in the Ph 1/2 study of Silmitasertib in children and young adults with relapsed refractory solid tumors

FDA Clears IND Application for BL-M17D1 in Advanced Solid Tumors

Alteogen enters into an Exclusive License Agreement to Develop and Commercialize SC ENHERTU® Enabled by Alteogen’s Hybrozyme™ Technology

Positive TNG462 Clinical Data reported and Update provided on PRMT5 Development Program

ALG.APV-527 Meets Important Trial Endpoints in Ph 1 Solid Tumor Trial

FDA approved Scemblix in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile

Applications submitted in the U.S. and EU seeking approval of DARZALEX FASPRO / DARZALEX as SC monotherapy for high-risk smoldering multiple myeloma

FAILED TRIAL: Ph 2/3 Study of Uproleselan Did Not Meet Primary Endpoint of EFS improvement in elderly 1L AML patients

Positive TNG462 Clinical Data reported and Update provided on PRMT5 Development Program

HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA (fruquintinib) Sales by Takeda

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Drug approvals

FDA approved obecabtagene autoleucel (Aucatzyl) for adults with R/R B-cell precursor acute lymphoblastic leukemia (ALL)

MHRA grants marketing authorisation for BALVERSA (erdafitinib) for PD-(L)1 inhibitor-treated adults with unresectable/metastatic urothelial carcinoma (UC) with FGFR3 alterations

FDA approved Scemblix in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile

DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the EC for patients with newly diagnosed multiple myeloma who are transplant-eligible

Regulatory news

FDA gives clearance to commence Ph 2 trial of leronlimab in patients with R/R MSS CRC

Type C Meeting granted with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed GBM

FDA extends PDUFA for zenocutuzumab

FDA Clears IND Application for BL-M17D1 in Advanced Solid Tumors

Trial results

Ph 1 and iMMagine-1 studies of anito-cel in R/R multiple myeloma patients continue to demonstrate durability and a manageable safety profile

ALG.APV-527 Meets Important Trial Endpoints in Ph 1 Solid Tumor Trial

FAILED TRIAL: Ph 2/3 Study of Uproleselan Did Not Meet Primary Endpoint of EFS improvement in elderly 1L AML patients

Positive KARISMA-Endoxifen Trial Results Reported

trial status

First Patients dosed in Ph 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma

U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025

Development of allogeneic CAR-NK cell therapy NKX019 in NHL to be discontinued

First patient dosed in the Ph 1/2 study of Silmitasertib in children and young adults with relapsed refractory solid tumors

Business news

Xenetic Biosciences Extends Research and Development Collaboration with The Scripps Research Institute to Advance DNase Platform

Alteogen enters into an Exclusive License Agreement to Develop and Commercialize SC ENHERTU® Enabled by Alteogen’s Hybrozyme™ Technology

HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA (fruquintinib) Sales by Takeda

AbbVie and EvolveImmune Therapeutics Announce Collaboration and Option-to-License Agreement to Develop Next-Gen Cancer Biotherapeutics

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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.