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FDA Fast Track Designation for Novel KIF18A Inhibitor VLS-1488 in Ovarian Cancer

October 8, 2024

Enhertu granted Priority Review in the US for patients with HER2-low/ultralow metastatic breast cancer who received at least one line of endocrine therapy

October 8, 2024

sBLA filed for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned

October 8, 2024

FDA Clears IND Application for REC-1245, a RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

October 8, 2024

FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers

October 8, 2024

ENHERTU® sNDA Submitted in Japan for Patients with HER2 Low/ultralow Metastatic Breast Cancer

October 8, 2024

Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma

October 8, 2024

Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or GEJ Cancer Expressing Claudin 18.2

October 2, 2024

BLA submitted for accelerated approval for Telisotuzumab Vedotin (Teliso-V) in Previously Treated NSCLC with c-Met protein overexpression based on Ph 2 LUMINOSITY trial (M14-239) data

October 2, 2024

Protocol amendment submitted for C-ERT trial in ovarian cancer

October 1, 2024

Orphan Drug Designation for LMP744 Cancer Treatment

October 1, 2024

Positive Interim Ph 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma Announced

October 1, 2024

FDA cleared IND for Ph 1 clinical study of IPH4502 in solid tumors

October 1, 2024

FDA Clears IND Application for KSQ-004EX eTIL Therapy

October 1, 2024

sNDA submitted to FDA for darolutamide + ADT combo in patients with mHSPC

October 1, 2024

FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors 

October 1, 2024

NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis

October 1, 2024

FDA Fast Track Designation For Narmafotinib In Advanced Pancreatic Cancer

September 24, 2024

Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer

September 24, 2024

Blenrep (belantamab mafodotin) combinations in R/R multiple myeloma accepted for regulatory review in Japan

September 24, 2024

Blenrep (belantamab mafodotin) combination receives Breakthrough Therapy Designation in China in R/R multiple myeloma

September 24, 2024

Positive FDA Meeting and Plans for Dasynoc NDA Resubmission Announced

September 24, 2024

FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment

September 24, 2024

FDA Clearance for Ph 1 Trial of CD-001 Announced

September 24, 2024

US FDA grants CF33-hNIS (VAXINIA) Orphan Drug Designation (ODD)

September 24, 2024
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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.