We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
GSK's Jemperli Gets EU Nod for Expanded Use in Endometrial Cancer
Read MoreHide Full Article
GSK plc (GSK - Free Report) announced that the European Commission has granted approval for the expanded use of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary, advanced or recurrent endometrial cancer.
The regulatory body has now approved Jemperli in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary, advanced or recurrent endometrial cancer who are candidates for systemic therapy in the European Union (“EU”).
The approval was expected as the Europe Medicines Agency’s Committee for Medicinal Products for Human Use recommended expanded use of Jemperli plus chemotherapy in the given patient population in December 2024.
Jemperli is presently approved in combination with chemotherapy as a frontline treatment for mismatch repair deficient (dMMR) or microsatellite instability-high primary, advanced or recurrent endometrial cancer in adult patients who are candidates for systemic therapy.
In the past year, shares of GSK have lost 15.4% compared with the industry’s decline of 14.2%.
Image Source: Zacks Investment Research
Latest Nod in EU Based on GSK's RUBY Part 1 Study
The latest approval for the expanded use of Jemperli plus chemotherapy in the EU was based on data from the phase III RUBY Part 1 study.
Data from the same showed that Jemperli plus chemotherapy led to a statistically significant overall survival (“OS”) benefit in the full population of patients with primary, advanced or recurrent endometrial cancer, indicating a 31% reduction in risk of death versus chemotherapy alone.
Also, treatment with Jemperli plus chemotherapy demonstrated a median OS of 44.6 months compared with 28.2 months for chemotherapy alone.
Jemperli was approved for similar expanded use in endometrial cancer in the United States in August 2024. The drug is also approved for second-line endometrial cancer and dMMR recurrent or advanced solid tumors in the United States.
Jemperli a Key Oncology Drug for GSK
In the first nine months of 2024, Jemperli recorded sales worth £318 million. Sales of the drug are being driven by new patient starts in the United States.
Some label expansion studies are ongoing on Jemperli, either as monotherapy or in combination with other oncology compounds in advanced non-small cell lung cancer, head and neck cancer, rectal cancer and colon cancer. Approval for expanded indications can potentially boost the drug’s sales in future quarters.
Jemperli, a PD-1 inhibitor, was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications.
Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
In the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.48 for 2025. In the past year, shares of VYGR have plunged 32.8%.
VYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 26%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
GSK's Jemperli Gets EU Nod for Expanded Use in Endometrial Cancer
GSK plc (GSK - Free Report) announced that the European Commission has granted approval for the expanded use of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary, advanced or recurrent endometrial cancer.
The regulatory body has now approved Jemperli in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary, advanced or recurrent endometrial cancer who are candidates for systemic therapy in the European Union (“EU”).
The approval was expected as the Europe Medicines Agency’s Committee for Medicinal Products for Human Use recommended expanded use of Jemperli plus chemotherapy in the given patient population in December 2024.
Jemperli is presently approved in combination with chemotherapy as a frontline treatment for mismatch repair deficient (dMMR) or microsatellite instability-high primary, advanced or recurrent endometrial cancer in adult patients who are candidates for systemic therapy.
In the past year, shares of GSK have lost 15.4% compared with the industry’s decline of 14.2%.
Image Source: Zacks Investment Research
Latest Nod in EU Based on GSK's RUBY Part 1 Study
The latest approval for the expanded use of Jemperli plus chemotherapy in the EU was based on data from the phase III RUBY Part 1 study.
Data from the same showed that Jemperli plus chemotherapy led to a statistically significant overall survival (“OS”) benefit in the full population of patients with primary, advanced or recurrent endometrial cancer, indicating a 31% reduction in risk of death versus chemotherapy alone.
Also, treatment with Jemperli plus chemotherapy demonstrated a median OS of 44.6 months compared with 28.2 months for chemotherapy alone.
Jemperli was approved for similar expanded use in endometrial cancer in the United States in August 2024. The drug is also approved for second-line endometrial cancer and dMMR recurrent or advanced solid tumors in the United States.
Jemperli a Key Oncology Drug for GSK
In the first nine months of 2024, Jemperli recorded sales worth £318 million. Sales of the drug are being driven by new patient starts in the United States.
Some label expansion studies are ongoing on Jemperli, either as monotherapy or in combination with other oncology compounds in advanced non-small cell lung cancer, head and neck cancer, rectal cancer and colon cancer. Approval for expanded indications can potentially boost the drug’s sales in future quarters.
Jemperli, a PD-1 inhibitor, was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications.
Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK's Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. (VYGR - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.48 for 2025. In the past year, shares of VYGR have plunged 32.8%.
VYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 26%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.