FDA rejects more drugs from China; indication of uterine Ca disparity; Cancer Vax controversy


China-based Hutchmed announced it has received a full response letter from the FDA, stating that the agency cannot approve the tyrosine kinase inhibitor surufatinib for advanced neuroendocrine tumors without support from a multi-region clinical trial.

Coherus and Junshi Biosciences also received a full response letter for the PD-1 inhibitor toripalimab for the treatment of advanced or metastatic nasopharyngeal cancer due to issues related to a “quality process change.”

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

The tobacco industry has agreed in principle to a settlement that sets out the terms of corrective advertising related to the potential health risks of tobacco use, as stated in the 2006 federal court ruling in United States vs. Philip Morris. (American Cancer Society)

A phase I/II study of sitravatinib and nivolumab (Opdivo) in previously treated renal cell carcinoma showed an 88.1% disease control rate and an 80% survival rate after a median follow-up of 18.7 months. (MD Anderson Cancer Center at the University of Texas, Science Translational Medicine)

Novartis announced that it has voluntarily halted production at two radioligand manufacturing sites and has temporarily halted screening and clinical trial enrollment of its radioligand products pending an investigation into potential quality issues in the manufacturing process.

A randomized phase III study demonstrated that topical imiquimod is a safe and effective alternative to surgery for high-grade vulvar squamous intraepithelial lesions. (The lancet)

A rare but aggressive form of cervical cancer appears to be driving the recent rise in cervical cancer mortality and the wide mortality gap among black women. (JAMA oncology)

A blood test that general practitioners can perform during routine care has shown promise for the early detection of ovarian cancer. (University of Manchester)

A new cancer immunotherapy strategy that trains T cells to recognize mutations specific to cancer cells has shown promise in preclinical tests. (Memorial Sloan Kettering Cancer Center, naturopathy)

An Idaho doctor who – without providing evidence – attributed a rise in cancer cases to immune damage caused by COVID vaccines has been accused of cancer misdiagnosis in a complaint to a medical review board. (Idaho Capital Sun)

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


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