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Clovis Oncology, Inc.

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Patrick J. Mahaffy, President and CEO, gave guidance for the CHMP opinion for Rociletinib. He stated, "Turning to our MAA filing in Europe, at the time of filing we agreed to provide a 120-day clinical data update. We received the initial questions in December and have also held clarification meetings with our rapporteurs. We plan to respond to the 120-day questions and provide the clinical update in May, which should result in a CHMP opinion by the end of the year."
Source: Q4 2015 earnings conference call, 2/25/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Rociletinib (CO-1686) EGFR mutationOncologyNon-Small Cell Lung Cancer (NSCLC) (1st line)Epidermal growth factor receptor (EGFR) inhibitorEpidermal growth factor

Mechanism of action: Rociletinib (CO-1686) is an orally available small molecule, irreversible inhibitor of epidermal growth factor receptor (EGFR) with potential antineoplastic activity. EGFR inhibitor CO-1686 binds to and inhibits mutant forms of EGFR, including T790M, thereby leading to cell death of resistant tumor cells. Compared to other EGFR inhibitors, CO-1686 inhibits T790M, a secondary acquired resistance mutation, as well as other mutant EGFRs and may have therapeutic benefits in tumors with T790M-mediated resistance to other EGFR tyrosine kinase inhibitors. This agent shows minimal activity against wild-type EGFR, hence does not cause certain dose-limiting toxicities.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-11-11

Results: Pending