FDA Rejects More China Drugs; Clue to Uterine Ca Disparity; Cancer-Vax Controversy

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Cancer cells with OncoBreak in the center.

China-based Hutchmed announced receipt of a complete response letter from the FDA, stating that the agency the tyrosine kinase inhibitor surufatinib for advanced neuroendocrine tumors without support from a multiregional clinical trial.

Coherus and Junshi Biosciences also for PD-1 inhibitor toripalimab as a treatment for advanced or metastatic nasopharyngeal carcinoma over issues related to a "quality process change."

AstraZeneca and Daiichi Sankyo announced that the FDA converted an accelerated approval to full approval of trastuzumab deruxtecan (Enhertu) for previously treated with anti-HER2 therapy.

The tobacco industry has agreed in principle to a settlement that lays out terms for related to the potential health risks of tobacco use, as required by the 2006 federal court decision in United States v Philip Morris. (American Cancer Society)

A phase I/II trial of sitravatinib and nivolumab (Opdivo) for produced a disease control rate of 88.1% and survival rate of 80% after a median follow-up of 18.7 months. (University of Texas MD Anderson Cancer Center, Science Translational Medicine)

Novartis announced it has voluntarily suspended production at two and has temporarily halted screening and enrollment in clinical trials involving the radioligand products, pending an investigation into potential quality issues in the manufacturing process.

A randomized, phase III trial showed that topical imiquimod is a safe and effective alternative to surgery for . (The Lancet)

A rare but aggressive form of appears to be driving recent increases in uterine cancer mortality, as well as the large mortality disparity affecting Black women. (JAMA Oncology)

A blood test that primary care physicians can perform during routine care showed promise for early detection of . (University of Manchester)

A new that involves training T cells to recognize mutations specific to cancer cells showed promise in preclinical testing. (Memorial Sloan Kettering Cancer Center, Nature Medicine)

An Idaho physician who attributed -- without offering proof -- a surge in cancer cases to COVID vaccine-induced immune damage has been accused of in a complaint to a medical review board. (Idaho Capital Sun)

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    Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined in 2007.