MedPage TodayFDA to Make Isotretinoin Prescribing Gender Neutral

For patients being prescribed isotretinoin, there used to be three risk categories: women of reproductive potential, women not of reproductive potential, and males. The new risk classifications are two: those who can become pregnant and those who cannot. This change was based on stakeholder feedback that gender-specific language can be a barrier to access for […]

American Medical AssociationAssessment of New Molecular Entities Approved for Cancer Treatment in 2020

Despite the pandemic interrupting trials and drug development in 2020, the US Food and Drug Administration (FDA) claims it is “full speed ahead” on the approval of novel cancer drug therapies. The authors of this Journal of the American Medical Association (JAMA) study wanted to verify these remarks, reviewing the FDA Hematology/Oncology Approvals website to […]

HMP CommunicationsFDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

This new indication marks the second FDA approval for sacituzumab govitecan (Trodelvy, Immunomedics) and was based on the phase 2, single-arm TROPHY-U-01 main efficacy endpoints in objective response rate (ORR) and duration of response (DOR). With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with metastatic urothelial cancer (mUC), […]