GlaxoSmithKline plc GSK announced that the FDA has granted accelerated approval to its biologics license application or BLA for anti PD-1 inhibitor Jemperli (dostarlimab-gxly). The drug is now approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, whose disease progressed on or after treatment with platinum-based regimen, as detected by an FDA-approved test.
The approval was granted under the FDA’s Real-Time Oncology Review pilot program. The regulatory body granted Breakthrough therapy designation to Jemperli for dMMR endometrial cancer in May 2019.
The approval was based on data from the dMMR endometrial cancer cohort of the ongoing multi-center open-label GARNET study which evaluated Jemperli for the given indication. Data from the same showed that treatment with Jemperli as a monotherapy led to an overall response rate of 42.3%, with complete response rate of 12.7% and partial response rate of 29.6% in the given patient population.
Per the company, the study represents the largest dataset of an anti-PD-1 monotherapy treatment in women with endometrial cancer.
Shares of Glaxo have risen 2.4% so far this year compared with the industry’s increase of 4.1%.
We note that endometrial cancer is the most common gynecologic malignancy in the United States, with limited treatment options for women whose disease progresses on or after first-line therapy. An estimated 60,000 new cases of endometrial cancer are expected to occur in the United States in 2021.
Hence, the above approval for Jemperli is likely to introduce a new treatment option for the given patient population, who until now had limited treatment options available.
Please note that dostarlimab is also being studied for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for treating advanced solid tumors or metastatic cancer.
We note that dostarlimab was added to GlaxoSmithKline’s pipeline following the Tesaro acquisition in January 2019. Dostarlimab was actually discovered by AnaptysBio ANAB and was licensed to Tesaro, Inc.
Zacks Rank & Stocks to Consider
Glaxo currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Catalent, Inc. CTLT and Repligen Corporation RGEN, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Catalent’s earnings estimates have been revised 1.8% upward for 2021 and 1.5% upward for 2022 over the past 60 days. The stock has rallied 8.8% year to date.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has surged 12.9% year to date.
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GlaxoSmithKline plc (GSK): Free Stock Analysis Report
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