Regulatory News ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications September 27, 2024Vol.50 No.36By Jacquelyn Cobb
Regulatory News Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover designThe agency accepts the invitation September 20, 2024Vol.50 No.35By Paul Goldberg
Regulatory News ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications July 26, 2024Vol.50 No.30By Jacquelyn Cobb and Paul Goldberg
Regulatory News ODAC unanimously upholds MRD as early endpoint across all settings in multiple myeloma April 26, 2024Vol.50 No.17By Jacquelyn Cobb
Regulatory News Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials March 29, 2024Vol.50 No.13By Paul Goldberg
Regulatory News ODAC votes in favor of two CAR T-cell therapies for MM after weighing FDA concerns about early deaths March 22, 2024Vol.50 No.12By Jacquelyn Cobb and Paul Goldberg
Conversation with The Cancer LetterRegulatory News FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLCPooled analysis finds correlations between early endpoints and OS in ICI trials March 15, 2024Vol.50 No.11By Matthew Bin Han Ong and Paul Goldberg
Regulatory News ODAC gives thumbs-up to imetelstat for MDS, upholding the value of transfusion independence March 15, 2024Vol.50 No.11By Jacquelyn Cobb and Paul Goldberg
Regulatory News FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies February 02, 2024Vol.50 No.05By Alexandria Carolan
Regulatory News Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approvalMeanwhile, NCI trial will assess clinical utility January 12, 2024Vol.50 No.02By Jacquelyn Cobb
