- US fast track designation for bone cancer treatment
- Designation based on positive data
- No approved therapies exists for disease
GSK (GSK) announced that the US FDA (Food and Drug Administration) has granted Breakthrough Designation to its experimental antibody drug conjugate candidate GSK’227 for treating a rare kind of bone cancer.
Breakthrough Designation Therapy is aimed at advancing the development and review of drugs which have the potential to treat a serious condition and where preliminary evidence suggests a ‘substantial’ improvement over currently available treatment.
The FDA’s decision is supported by data from a mid-stage clinical study, ARTEMIS-002 which was conducted on more than 60 patients, including 42 with osteosarcoma, a rare bone cancer.
GSK shares fell 2.8p or 0.2% to £13.46, slightly less than the drop in the benchmark FTSE 100 index. Over the last 12-monts the shares are down 13%, underperforming the 7% gain for the FTSE 100 index.
WHAT DID THE COMPANY SAY?
Hesham Abdullah, head of oncology research and development at GSK said: ‘This latest regulatory designation for GSK'227 exemplifies the potential of our targeted antibody drug congugate in patients with difficult to treat cancers.
‘For patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns a second time, and chemotherapy provides limited benefit in this setting.’
In 2024, GSK was granted exclusive worldwide rights, excluding mainland China, Hong Kong, Macau, and Taiwan from Hansoh Pharma to progress clinical development and commercialisation of GSK’227.
Osteosarcoma affects young children and adults and is the most common bone cancer, accounting for 20% to 40% of all bone cancers. It is considered a rare disease as it occurs in less than 1% of all new cancer diagnoses.
Following first line of treatment with chemotherapy, treatment options for patients where the disease has returned or stopped responding to treatment are severely limited, with no approved therapies.
