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MAA submitted to the EMA for Zepzelca® (lurbinectedin) + Tecentriq for the maintenance treatment of adult patients with ES-SCLC

May 27, 2025

CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer

May 27, 2025

FDA ODAC votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

May 27, 2025

European orphan drug designation for HLX22 in gastric cancer

May 27, 2025

NMPA CDE grants Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC

May 27, 2025

Fourth NDA for sacituzumab tirumotecan (sac-TMT) Accepted by NMPA CDE

May 27, 2025

FDA Clears IND Application for Ph 1/2 trial of AVZO-1418

May 27, 2025

Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with R/R B-ALL

May 27, 2025

FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC

May 27, 2025

FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab + Chemo for Patients With R/R DLBCL

May 27, 2025

EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients

May 21, 2025

U.S. FDA granted Fast Track Designation for ZL-1310 for Treatment of Extensive-Stage SCLC

May 21, 2025

IND application for Ph 1 trial of Penetrium™ in combination with docetaxel voluntary withdrawn 

May 21, 2025

CNS Pharmaceuticals Acquires Orphan Drug Designation for Abeotaxane TPI 287

May 21, 2025

FDA Clears IND for Ph 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need

May 21, 2025

IND cleared for ERAS-0015 and IND submitted for ERAS-4001; Ph 1 monotherapy data for both programs expected in 2026

May 21, 2025

FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for B7-H3 CAR T-cell therapy for incurable pediatric brain tumors

May 21, 2025

CPO301 granted the fast track designation by U.S. FDA for the treatment of adult patients with NSCLC

May 21, 2025

IND Clearance obtained for Ph 1b/2 Trial of LP-184 + ICIs in NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression

May 13, 2025

Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer

May 13, 2025

FDA Advisory Committee Announced for UGN-102 for Recurrent Low-Grade Intermediate-Risk NMIBC

May 13, 2025

FDA lifts the clinical hold on IND applications for the EBVALLO™ (tabelecleucel) program

May 13, 2025

IND Clearance obtained for LP-184 for Ph 1b/2 Trial in TNBC

May 13, 2025

IND application submitted to the U.S. FDA for UTRxM1-18 for targeting c-MYC driven cancers

May 13, 2025

Mesutoclax Receives Breakthrough Therapy Designation from China’s NMPA

May 13, 2025
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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.