rociletinibTreatment for Non-Small Cell Lung Cancer
Clovis Oncology Terminates Enrollment in all Ongoing Sponsored Clinical Studies of Rociletinib
BOULDER, Colo.--(BUSINESS WIRE)--May 5, 2016-- Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter ended March 31, 2016, and provided an update on the Company’s clinical development programs and regulatory outlook for the remainder of 2016.
“We are very disappointed in the outcome for rociletinib, as there is a need for additional options for this difficult to treat disease,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
In a recent meeting with the FDA, Clovis was notified that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016. The FDA issues a CRL to indicate that their review of an application is complete and that the application is not ready for approval. In anticipation of receiving the CRL, Clovis has terminated enrollment in all ongoing sponsored clinical studies of rociletinib. 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 In addition, Clovis has withdrawn its MAA for rociletinib previously filed with European regulatory authorities.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 our staff and contractor positions by 35 percent by the end of 2016, compared to year-end 2015.
Rociletinib is an oral, mutant-selective inhibitor of epidermal growth factor receptor (EGFR). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M. Clovis holds worldwide rights for rociletinib.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates, the corresponding development pathways of our companion diagnostics, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
Source: Clovis Oncology, Inc.
Posted: May 2016
- Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib - April 12, 2016
- Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib - December 15, 2015
- Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing - November 16, 2015
- Clovis Oncology Announces U.S. and E.U. Regulatory Milestones for Rociletinib in the Treatment of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer - November 15, 2015
- Clovis Oncology Submits NDA for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer - August 3, 2015
- Clovis Oncology Initiates Rolling NDA Submission for Rociletinib in Advanced EGFR-Mutant Non-Small Cell Lung Cancer - July 1, 2015
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