The U.S. FDA has granted Datar Cancer Genetics Ltd. a breakthrough device designation for a blood test to detect early-stage prostate cancer. The circulating tumor cell (CTC) detection blood test can identify early-stage prostate cancer in men of age 55-69 years at around 99% accuracy.

Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.

Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.

Immunogen Inc. and Eli Lilly and Co., having already seen a collaboration collapse in 2018, will try it again. Immunogen granted the exclusive rights to research, develop and commercialize antibody-drug conjugates (ADCs) that are directed toward targets Lilly will select. Waltham, Mass.-based Immunogen will receive $13 million up front from Lilly and is eligible to receive another $32.5 million in exercise fees if Lilly licenses all the targets. Down the road, Immunogen could receive as much as $1.7 billion in exercise fees and milestones payments.

PERTH, Australia – Impedimed Ltd.’s L-Dex bioimpedance technology could quickly become the standard of care for measuring cancer-related lymphedema following clinical trial results that showed a 59% relative reduction in progression compared to the standard of care, Impedimed CEO Rick Carreon told BioWorld.