Clovis terminates enrollment for clinical trials of CO 1686 (rociletinib) in non-small cell lung cancer and withdraws marketing application in EU- Clovis
In a meeting with the FDA, Clovis was notified that it could anticipate receiving a Complete Response Letter (CRL) for the CO 1686 (rociletinib) NDA for non-small cell lung cancer (NSCLC) on or before the PDUFA date of June 28, 2016. In anticipation of receiving the CRL, Clovis has terminated enrollment in all ongoing sponsored clinical studies of rociletinib for NSCLC. Clovis will continue to provide drug to patients whose clinicians recommend continuing rociletinib therapy. In addition, Clovis has withdrawn its MAA for rociletinib previously filed with European regulatory authorities.
Related to terminating enrollment in all ongoing sponsored clinical studies of rociletinib, Clovis is reducing its staff, eliminating contractor positions and delaying or eliminating planned new positions. This will result in the reduction of staff and contractor positions by 35 percent by the end of 2016, compared to year-end 2015.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins