GSK plc, Breakthrough Therapy and ADC

GSK's ADC Drug Gets FDA's Breakthrough Tag for Rare Bone Cancer
GSK plc GSK announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed or refractory osteosarcoma in adult patients whose disease progressed on at least two prior lines of therapy.
FDA Grants Breakthrough Therapy Designation To GSK's GSK5764227 For Bone Cancer
GSK plc (GSK, GSK.L) said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, its
US FDA grants breakthrough therapy designation to GSK’s B7-H3-targeted ADC, GSK’227 to treat relapsed or refractory osteosarcoma
US FDA grants breakthrough therapy designation to GSK’s B7-H3-targeted ADC, GSK’227 to treat relapsed or refractory osteosarcoma: London, UK Wednesday, January 8, 2025, 10:00
BRIEF—FDA Breakthrough status for GSK’227 in osteosarcoma
UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy.
GSK bags breakthrough status for bone cancer drug
The FDA previously designated the ADC as a breakthrough drug for relapsed or refractory extensive-stage small-cell lung cancer (SCLC), with the EMA awarding Priority Medicine (PRIME) status to the drug for this use last year.
GSK hails FDA breakthrough therapy designation for bone cancer drug
(Alliance News) - GSK PLC on Tuesday said the US Food & Drug Administration has granted a breakthrough therapy designation to its treatment for a form of bone cancer.
GSK nears $1bn deal for biotech developing drug for rare tumour
GSK is nearing a $1bn deal to buy a US biotech developing a treatment for rare gastrointestinal tumours, as the UK drugmaker races to expand its oncology business. The UK group is in advanced talks to buy privately owned biotech IDRx,
Targeted Oncology15h
FDA Grants B7-H3–Targeted ADC Breakthrough Status in Osteosarcoma
The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of ...
Cancer Therapy Advisor1d
Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for Rel/Ref Osteosarcoma
GSK5764227 (HS-20093) is a novel antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload.
GSK’s GSK’227 receives FDA BTD for treating adults with relapsed osteosarcoma
GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for GSK5764227, GSK’227, ...
Pharmabiz22d
GSK’s B7-H3-targeted ADC, GSK’227, receives EMA PRIME designation in relapsed extensive-stage small-cell lung cancer
GSK plc announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being ...
Monthly Prescribing Reference1d
Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for R/R Osteosarcoma
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to GSK5764227 (GSK’227) for the treatment of adult patients with relapsed or refractory (R/R) osteosarcoma who have ...