British pharmaceutical firm GlaxoSmithKline (LON: GSK) have said on Tuesday that they are seeking US approval for a multiple myeloma drug.
GSK have seen a relatively stable 2019, with the firm reporting strong trading figures throughout the year.
Most notably, GSK reported a lift in their lift in their annual profit forecasts as the firm impressively told shareholders that turnover rose 11% to £9.39 billion in the three months ended Sept. 30 from a year earlier.
Additionally, last week the firm saw its shares boosted as GSK told the market about the submission of a new drug application to the US Food & Drug Administration, seeking approval of fostemsavir, through ViiV Healthcare.
ViiV Healthcare is majority owned by GSK, with rival firms Pfizer Inc and Shionogi Ltd as a minority shareholders.
In similar fashion to last week, GSK said that it had applied for US approval for its experimental multiple myeloma drug which had shown positive results in almost a third of patients.
This certainly is an interesting move by GSK, as rivals Johnson & Johnson (NYSE: JNJ) offer a similar type of drug, which could set up a war between the two pharmaceutical titans.
New data from the treatment, belantamab mafodotin, showed 30 of 97 patients experienced a reduction in their myeloma cells at the end of a mid-stage study, DREAMM-2.
The trial was testing GSK2857916, in patients who had received four to seven prior other treatments, including J&J and Genmab’s (CPH: GMAB) Darzalex.
GSK has submitted a marketing application to the U.S. Food and Drug Administration (FDA) in the 2.5 mg/kg dose. If approved, belantamab mafodotin would be the first anti-B-cell maturation antigen (BCMA) agent available in the United States, the company said.
Belantamab mafodotin targets the BCMA protein in cells characteristic of multiple myeloma – an area of focus for many drugmakers.
Axel Hoos, GSK’s oncology research and development head, said the rate of response – or the number of patients that experience a reduction in myeloma cells – should go up with every earlier cycle of treatment.
“We are pretty confident that we can actually achieve the same (response rates) if not more and eventually even beat Darzalex in some settings,” he said.
Shares in GSK were 0.15% to the good on Tuesday afternoon and trade at 1,766p. 17/12/19 12:57BST
