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GSK PLC on Friday said the European Medicines Agency has accepted a marketing authorisation application for momelotinib, its treatment for myelofibrosis, a rare bone marrow cancer. Additionally, it announced positive results from a trial investigating Jemperli.
GSK is a London-based multinational pharmaceutical and biotechnology company.
Myelofibrosis is a rare bone marrow cancer, characterised by constitutional symptoms, splenomegaly, and progressive anaemia. Splenomegaly is an enlarged spleen.
The company said momelotinib could address the significant medical needs of myelofibrosis patients with anaemia. GSK said that momelotinib has a ‘differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase 1, and JAK2 and activin A receptor type I’.
Separately, GSK also announced positive headline results from a trial investigating dostarlimab, sold under the brand name Jemperli, with standard-of-care chemotherapy followed by Jemperli when compared to chemotherapy plus a placebo in adults with primary advanced or recurrent endometrial cancer.
GSK said the trial met its primary endpoint of progression free survival and showed statistically significant and clinically meaningful benefit.
Hesham Abdullah, GSK senior vice president & global head of Oncology Development said: ‘Patients with primary advanced or recurrent endometrial cancer have limited treatment options. Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy.’
He added: ‘Based on these positive headline results from the Ruby phase III trial, GSK intends to seek regulatory approvals for a potential new indication for dostarlimab in the treatment of primary advanced or recurrent endometrial cancer.’
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. It is the most common gynaecological cancer in the US and the second most common gynaecological cancer globally.
last month, GSK said it had started the process to withdraw US marketing authorisation for its cancer drug, Blenrep, on the request of the US Food & Drug Administration. Blenrep, or belantamab mafodotin, is an antibody drug conjugate designed to treat adult patients with relapsed or refractory multiple myeloma.
Shares were down 0.9% at 1,403.00 pence each on Friday morning in London.
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