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The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

Pembrolizumab demonstrated an improvement in progression-free survival in the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer, meeting one of the primary end points of the phase III KEYNOTE-177 trial.

From 2001 to 2017, the cancer death rates continued to decline in the United States, and these decreases were observed in all major racial and ethnic groups, as well as in males, females, adolescents, young adults, and children. However, the rates of cancer incidence for all cancers slightly increased in females from 2012 to 2016, according to the Annual Report to the Nation on the Status of Cancer, which was published in&nbsp;Cancer.<sup>&nbsp;</sup>

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.