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GSK Drops TIGIT Drug, FDA Clears First At-Home Cervical Screening Device, Merck Gains Welireg Approval

Published about 1 month ago • 1 min read

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FDA Approves First At-Home Cervical Cancer Screening Device

Context: Cervical cancer screening remains underutilized, particularly among women facing barriers to in-person care.

What's New? The FDA has approved the first self-collection device for HPV testing, allowing women to collect samples at home for laboratory-based cervical cancer screening.

Why it Matters? This innovation may expand access to early detection, especially in underserved populations, and marks a pivotal shift in women’s health and cancer prevention strategies.

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Merck Gains Third FDA Approval for Welireg in Cancer Indications

Context: Welireg (belzutifan) is a HIF-2α inhibitor originally developed for kidney cancer and Von Hippel-Lindau disease.

What's New? The FDA has approved Welireg for advanced renal cell carcinoma (RCC) following prior therapy, based on a pivotal trial showing strong response rates and manageable safety profile. This marks its third approved indication.

Why it Matters? The approval broadens Merck’s oncology reach and establishes Welireg as a versatile asset in the company’s renal cancer franchise, especially after its acquisition of Peloton Therapeutics in 2019.

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GSK Shuts Down TIGIT Program After Mid-Phase Survival Data Disappoint

Context: TIGIT checkpoint inhibitors have faced increasing scrutiny following a series of high-profile setbacks across the class.

What's New? GSK is discontinuing development of its TIGIT candidate belrestotug after a mid-phase trial showed no survival benefit. The move also affects partner iTeos Therapeutics, which will refocus its pipeline amid cost-cutting efforts.

Why it Matters? The failure reflects waning enthusiasm for TIGIT-targeted immunotherapies and raises questions about biomarker strategies needed to salvage this checkpoint pathway.

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Enhancing Access and Retention in Oncology Trials Through Decentralization

Context: Decentralized clinical trials (DCTs) have gained momentum, especially in oncology, where site visits can limit patient participation and diversity.

What's New? A new Fortrea whitepaper outlines how hybrid and decentralized models improve access, retention, and compliance in oncology trials, with practical insights on logistics, data capture, and patient engagement.

Why it Matters? As oncology trials grow in complexity, decentralization offers a path to broader enrollment, greater equity, and real-world relevance—key goals for modern clinical research.

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Cullinan and Taiho Reveal Positive NSCLC Data Ahead of FDA Filing Context: Cullinan Oncology and Taiho are developing CLN-081, an EGFR exon 20 insertion–targeting therapy for NSCLC—a mutation subtype with limited approved options. What's New? At ASCO, the companies presented data showing a response rate of 41% and a 12.7-month median duration of response for CLN-081. The results are expected to support an FDA submission in the second half of 2024. Why it Matters? These findings position...

about 1 month ago • 1 min read

Roche’s Itovebi Cuts Risk of Death by 33% in HER2-Positive Breast Cancer Context: HER2-positive breast cancer remains an aggressive subtype despite advances in targeted therapies. What's New? In updated data presented at ASCO, Roche’s anti-HER2 therapy Itovebi (trastuzumab duocarmazine) reduced the risk of death by 33% in pretreated HER2-positive breast cancer, significantly improving overall survival compared to standard therapies. Why it Matters? This reinforces Itovebi’s growing role in...

about 1 month ago • 1 min read