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Genentech, Inc.
COVID-19 Information

Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

Genentech Initiates Phase III Clinical Trial Of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia

COVID-19 response page

On March 23, 2020, we announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. Learn more about the COVACTA clinical trial here.

Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).

Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Stage
Phase 3
Company Type
Late Onset Intervention
Non-Small Cell Lung Cancer

The purpose of this expanded access program (EAP) is to provide early access to divarasibto participants with KRAS G12C-positive (KRAS G12C+) advanced or metastatic non-smallcell lung cancer (NSCLC), prior to divarasib becoming commercially available in theUnited States.

ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer

The primary objective of this expanded access program (EAP) is to provide early access togiredestrant for participants with estrogen receptor-positive (ER+), human epidermalgrowth factor receptor 2-negative (HER2-) early breast cancer (eBC) or locallyadvanced/metastatic breast cancer (LA/mBC) prior to commercial availability in the UnitedStates.