GlaxoSmithKline Stock – FDA approves GSK’s endometrial cancer therapy
U.S.-listed shares of GlaxoSmithKline
were down 1.4% in trading on Thursday after the Food and Drug Administration said it had granted accelerated approval to the company’s endometrial cancer treatment. The immunotherapy, which was called dostarlimab and is now named Jemperli, is approved to treat patients with severe forms of this kind of cancer who have a genetic feature known as dMMR. About one-quarter of patients with this kind of cancer have dMMR tumors, the FDA said in a statement. A clinical trial with 71 participants found that Jemperli got rid of or reduced dMMR tumors in 42% of the patients. The regulator also said that additional trials are needed to back up the clinical data — the approval is an “accelerated” decision based on unmet need — and those studies are already underway. A GSK spokesperson did not immediately respond to a request for Jemperli’s price. GSK’s stock has gained 2.4% so far this year, while the S&P 500
is up 10.2%.