Glaxo's (GSK) Jemperli Gets FDA Approval for New Indication

GlaxoSmithKline plc GSK announced that the FDA has granted accelerated approval to anti PD-1 inhibitor Jemperli (dostarlimab-gxly) for a new indication. The drug is now approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours, whose disease progressed on or after prior treatment, having no satisfactory alternative treatment option available, as detected by an FDA-approved test. This is the second FDA-approved indication for Jemperli.

The approval was based on collective data from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing multi-center open-label GARNET study.

Data from the same showed that treatment with Jemperli led to an objective response rate of 41.6% across dMMR solid tumors, with a complete response rate of 9.1% and a partial response rate of 32.5%. Also, 95% of patients had duration of response of six months or longer.

Shares of Glaxo have risen 15% so far this year compared with the industry’s rally of 18.4%.

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Jemperli was approved for second-line endometrial cancer in the United States and the EU in April 2021. The approval was granted under the FDA’s Real-Time Oncology Review pilot program.

Jemperli 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 licensed to Tesaro.

Zacks Rank & Stocks to Consider

Glaxo currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen Corporation RGEN and Vertex Pharmaceuticals Incorporated VRTX, 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.

Repligen’s earnings estimates have been revised 22.1% upward for 2021 and 17.9% upward for 2022 over the past 60 days. The stock has surged 34.1% year to date.

Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 6.4% upward for 2022 over the past 60 days.

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