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Linkedin

FDA Grants Priority Review of sBLA for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

December 11, 2023

Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

December 11, 2023

IND Submission Announced for GTB-3650 for Treatment of CD33+ Leukemia

December 11, 2023

TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer

December 11, 2023

FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma

December 11, 2023

FDA granted “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic EDV (EnGeneIC Dream Vector)

December 11, 2023

Positive EU CHMP Opinion for KEYTRUDA Plus Gemcitabine and Cisplatin as 1L Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

December 4, 2023

US FDA Accepts for Priority Review Application for Breyanzi (lisocabtagene maraleucel) for R/R CLL/SLL

December 4, 2023

FDA granted BTD and EMA application validated for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of R/R Follicular Lymphoma

December 4, 2023

2nd Independent Safety Review of the ASPIRE Registration Clinical Trial Announced: Recommended Continuation with no Trial Modification

December 4, 2023

U.S. FDA Fast Track Designation for BI 764532 for the Potential Treatment of Advanced or Metastatic Large-Cell Neuroendocrine Carcinoma of the Lung

December 4, 2023

FDA Grants Orphan Drug Designation for LP-284 in High-Grade B-cell Lymphomas (HGBL)

December 4, 2023

sBLA submitted to US FDA for obecabtagene autoleucel (obe-cel) for Patients with R/R Adult B-Cell ALL

December 4, 2023

U.S. FDA Fast Track Designation for Zotatifin in Combination with Fulvestrant and Abemaciclib for Treatment of ER+/HER2- Advanced Metastatic Breast Cancer

December 4, 2023

FDA Grants Priority Review to sBLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

December 4, 2023

FDA Orphan Drug Designation for LYL845 for the Treatment of Melanoma

December 4, 2023

Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types

December 4, 2023

FDA Plans ODAC Review, Delays PDUFA Date for Idecabtagene Vicleucel

December 4, 2023

sBLA submitted to to U.S. FDA Seeking Approval of RYBREVANT + Chemo for the Treatment of Patients with EGFRm NSCLC Who Progressed on or after Osimertinib

December 4, 2023

FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic CRPC

October 31, 2023

Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024

October 31, 2023

EMA accepted the MAA for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with FRα-positive, platinum-resistant epithelial ovarian cancer

October 31, 2023

Tagrisso plus chemo granted Priority Review in the US for patients with EGFR-mutated advanced NSCLC

October 25, 2023

Positive CHMP opinion recommending approval of Jemperli (dostarlimab) + chemo as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer

October 25, 2023

BRUKINSA Receives Positive Recommendation from NICE in U.K. for Adult Patients with CLL

October 25, 2023
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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.