Linkedin
RLS logo_header
Linkedin

TOP STORIES from the week

Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours

FDA Accepts Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease; PDUFA Jan 2027

First patients dosed with [212Pb]VMT-α-NET and [212Pb]PSV359 in two new cohorts of Ph 1/2a studies in neuroendocrine tumors and solid tumors

FDA Orphan Drug Designation for CLN-049 in R/R AML

Cytovation to Evaluate Getacatetide (CY-101) in Combination with Tislelizumab in CRC

Enhertu approved for use before surgery based on DESTINY-Breast11 Ph 3 trial and following surgery based on DESTINY-Breast05 Ph 3 trial in HER2-positive early breast cancer

FDA Accepts Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease; PDUFA Jan 2027

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

First Patient Dosed in ASPENOVA Ph 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline

Stay up to date with OTW

Get all oncology clinical development news in your inbox

Drug approvals

Datroway approved in the US in 1L metastatic TNBC patients not PD-1/PD-L1 inhibitor candidates

US FDA Approves INQOVI® in Combination with Venetoclax in AML Patients Ineligible for Intensive Induction Chemo

Enhertu approved for use before surgery based on DESTINY-Breast11 Ph 3 trial and following surgery based on DESTINY-Breast05 Ph 3 trial in HER2-positive early breast cancer

BEQALZI™ (sonrotoclax) Approved by US FDA for R/R Mantle Cell Lymphoma

Regulatory news

Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours

FDA Accepts Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease; PDUFA Jan 2027

FDA Orphan Drug Designation for CLN-049 in R/R AML

Approval of Toripalimab NDA for 1L HER2 Expressing Urothelial Carcinoma Announced

Trial results

Serplulimab Achieves 42.5% pCR Rate in Neoadjuvant Colon Cancer

Ph 3 Trial of Sacituzumab Tirumotecan (sac-TMT) vs Chemo as 1L Treatment for Advanced TNBC Met Primary Endpoint of PFS 

Ph 2 ARASEC Data Supports the Efficacy and Safety of NUBEQA® (darolutamide) Plus ADT in Patients with Metastatic CSPC

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

trial status

First patients dosed with [212Pb]VMT-α-NET and [212Pb]PSV359 in two new cohorts of Ph 1/2a studies in neuroendocrine tumors and solid tumors

First patient dosed in Spain in Ph 2 HLX43-NSCLC201 trial of HLX43 for the treatment of advanced NSCLC

First patient dosed in Ph 1 trial of HLX316 in advanced/metastatic solid tumors

First Patient Dosed with MST-0312 in Ph 1 STARLYS Trial

Business news

Liminatus Pharma Announces Proposed Merger with InnocsAI to Expand Oncology Cell Therapy Pipeline

Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload

Cytovation to Evaluate Getacatetide (CY-101) in Combination with Tislelizumab in CRC

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline

Archive

2025

2024

2023

2022

2021

2020

2019

2018