Clovis Terminates Development of Lung Cancer Candidate

Clovis Oncology is stopping development of the lung cancer candidate rociletinib after the FDA warned the company of a potential complete response letter.

FDA officials informed Clovis that it is unlikely to approve the company’s NDA for the investigational drug — which is intended to treat advanced non-small cell lung cancer — and said the company should receive the CRL within the next two months, Clovis said.

As a result, Clovis stopped enrollment in clinical trials associated with the candidate’s development, withdrew its marketing authorization applications with European regulatory agencies and announced that it will cut its staff by 35 percent later this year.