FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

Sen. Richard J. Durbin (D-IL) has asked Amgen to provide copies of the company’s communications with FDA related to the dosage of Lumakras (sotorasib), a KRAS inhibitor marketed under an accelerated approval for non-small cell lung cancer.

FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.

May 17, 2024

Vol.50 No.20

Cancer History Project Conversation with The Cancer Letter

2024 Karnofsky Award winner Lillian Siu talks about her career in phase I studies, ctDNA, and her mentor’s “evil red pencil”

Lillian L. Siu discovered her passion while perusing employment ads in the Journal of Clinical Oncology.

OCE’s Project 5 in 5 seeks to inspire pragmatic innovation

If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like?

May 10, 2024

Vol.50 No.19

By Steven C. Cunningham, Donna R. Rivera, Richard Pazdur, Kelly J. Norsworthy and Jennifer Gao

Clinical Roundup

AI-based biomarker stratifies metastasis risk in patients with BCR post-prostatectomy

ArteraAI has validated its first multimodal artificial intelligence digital pathology-based post-radical prostatectomy biomarker for stratifying risk of metastasis and identifying differential absolute benefit for the addition of hormone therapy to salvage radiation therapy in radical prostatectomy patients with biochemical recurrence.

May 10, 2024

Vol.50 No.19

Clinical Roundup

AI tool predicts success of focal therapy for prostate cancer

Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, unveiled the results of a new UCLA study examining the role of AI in identifying tumor margins and predicting the efficacy of focal therapy treatments.

May 10, 2024

Vol.50 No.19

FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

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