The accelerated approval of dostarlimab (Jemperli) could allow eligible patients with biomarker-defined rectal cancer to avoid chemotherapy, radiotherapy, and surgery.

Die US-Arzneimittelbehörde FDA hat Dostarlimab (Jemperli) beschleunigt für Erwachsene mit lokal fortgeschrittenem Rektumkarzinom im Stadium II/III mit durch einen von der FDA autorisierten Test nachgewiesenem MSI-H- oder dMMR-Status zugelassen, was m

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untrea

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untrea

GSK (LSE:GSK) on Monday announced that interim results from its phase II AZUR-1 trial show that 76% of evaluable patients with stage II and III MSI-H/dMMR…

Reported Sunday, Oct 25 - 5:29pm EDT (TheFly subscription required to read more.)

The FDA approved a treatment for rectal cancer tumors with a specific genetic signature that uses only the immunotherapy Jemperli, allowing some patients to be successfully treated without surgery, ra...

FDA has granted an accelerated approval to dostarlimab-gxly (Jemperli), making it the first and only immunotherapy appro

2026年10月19日、米国FDAは、特定の局所進行直腸がんに対する免疫チェックポイント阻害薬ドスタルリマブ（商品名：Jemperli／ジェンペルリ、開発・販売：GSK［グラクソ・スミスクライン］）を迅速承認したとのニュース。直腸がんの治療では、化学療法や放射線療法、さらには直腸の一部または全部を切除する手術が必要になることがある。特に、がんの位置や進行状況によっては肛門を温存できず、永久的な人工...

Some people with rectal cancer may now be able to skip chemotherapy, radiation and surgery. The U.S. Food and Drug Administration (FDA) on Monday approved the immunotherapy Jemperli (dostarlimab-gxly)...

A groundbreaking immunotherapy treatment for rectal cancer, developed through pioneering research at Memorial Sloan Kettering Cancer Center (MSK) with critical early-stage funding from Swim Across America, has received accelerated approval from the U.S. Food and Drug Administration (FDA). The historic approval of Jemperli (dostarlimab) on Oct. 19, 2026, marks a major advancement in cancer care, offering certain patients with locally advanced rectal cancer the possibility of eliminating their cancer without chemotherapy, radiation or surgery. The FDA approval builds on research conducted by Luis Diaz Jr., MD, and Andrea Cercek, MD, gastrointestinal oncologists at Memorial Sloan Kettering Cancer Center, whose pioneering clinical trials demonstrated that immunotherapy alone could eliminate tumors in patients with a specific genetic mutation, as reported in the April 27, 2025, issue of The New England Journal of Medicine and a previous June 5, 2022, report in The New England Journal of Medicine. Swim Across America provided critical grant funding for the early research and subsequent clinical trials through its longstanding support of immunotherapy research at MSK, including the Swim Across America Lab, funded by Swim Across America – Long Island Sound and Swim Across America – Nassau-Suffolk. The FDA granted accelerated approval to Jemperli, developed by pharmaceutical...

The GSK cancer immunotherapy Jemperli is now approved for treating advanced cases of rectal cancer harboring a particular genetic signature. It’s a label expansion for Jemperli, which was initially ap...

FDA grants accelerated approval to GSK’s Jemperli for adults with stage II–III dMMR/MSI‑H locally advanced rectal cancer, potentially avoiding surgery.

GSK's PD-1 inhibitor Jemperli has been cleared by the FDA as the first pre-operative cancer immunotherapy for rectal cancer.

A new FDA-approved drug may let some rectal cancer patients avoid chemo, radiation, and surgery. The immunotherapy Jemperli offers a less invasive treatment option for early-stage cases.

A GSK informou que a Administração de Alimentos e Medicamentos dos Estados Unidos (FDA, na sigla em inglês) aprovou o Jemperli como imunoterap...

Most patients with complete response on dostarlimab avoided surgery for a year or more

Some people with rectal cancer may now be able to skip chemotherapy, radiation and surgery. The U.S. Food and Drug Administration (FDA) on Monday approved the immunotherapy dostarlimab-gxly (Jemperli) for certain adults with rectal cancer that hasn't been treated yet. The...

GSK (LSE:GSK) on Monday announced that the US Food and Drug Administration has approved Jemperli (dostarlimab) as the first and only immunotherapy for…