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

FDA Rejects Extra China Medication; Clue to Uterine Ca Disparity; Most cancers-Vax Controversy

China-based Hutchmed introduced receipt of a whole response letter from the FDA, stating that the company can’t approve the tyrosine kinase inhibitor surufatinib for superior neuroendocrine tumors with out help from a multiregional scientific trial.

Coherus and Junshi Biosciences additionally acquired a whole response letter for PD-1 inhibitor toripalimab as a therapy for superior or metastatic nasopharyngeal carcinoma over points associated to a “high quality course of change.”

AstraZeneca and Daiichi Sankyo introduced that the FDA transformed an accelerated approval to full approval of trastuzumab deruxtecan (Enhertu) for unresectable or metastatic HER2-positive breast most cancers beforehand handled with anti-HER2 remedy.

The tobacco trade has agreed in precept to a settlement that lays out phrases for corrective promoting associated to the potential well being dangers of tobacco use, as required by the 2006 federal courtroom resolution in United States v Philip Morris. (American Most cancers Society)

A section I/II trial of sitravatinib and nivolumab (Opdivo) for beforehand handled renal cell carcinoma produced a illness management price of 88.1% and survival price of 80% after a median follow-up of 18.7 months. (College of Texas MD Anderson Most cancers Middle, Science Translational Drugs)

Novartis introduced it has voluntarily suspended manufacturing at two radioligand manufacturing services and has briefly halted screening and enrollment in scientific trials involving the radioligand merchandise, pending an investigation into potential high quality points within the manufacturing course of.

A randomized, section III trial confirmed that topical imiquimod is a protected and efficient various to surgical procedure for vulvar high-grade squamous intraepithelial lesions. (The Lancet)

A uncommon however aggressive type of uterine most cancers seems to be driving latest will increase in uterine most cancers mortality, in addition to the massive mortality disparity affecting Black girls. (JAMA Oncology)

A blood take a look at that main care physicians can carry out throughout routine care confirmed promise for early detection of ovarian most cancers. (College of Manchester)

A brand new most cancers immunotherapy technique that entails coaching T cells to acknowledge mutations particular to most cancers cells confirmed promise in preclinical testing. (Memorial Sloan Kettering Most cancers Middle, Nature Drugs)

An Idaho doctor who attributed — with out providing proof — a surge in most cancers instances to COVID vaccine-induced immune harm has been accused of most cancers misdiagnosis in a criticism to a medical evaluate board. (Idaho Capital Solar)

  • author['full_name']

    Charles Bankhead is senior editor for oncology and in addition covers urology, dermatology, and ophthalmology. He joined MedPage Immediately in 2007. Comply with

Learn Extra

Leave a Comment

Your email address will not be published.