Celgene Corporation
Sep 7, 2017
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Celgene Provides Update on the Fusion™ Clinical Program

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION™ program. The trials are testing IMFINZI™ (durvalumab), an anti-PD-L1 antibody, in combination with immunomodulatory and chemotherapy agents in blood cancers such as multiple myeloma, chronic lymphocytic leukemia and lymphoma.

The decision by the FDA was based on risks identified in other trials for an anti-PD-1 antibody, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents. In the FUSION™ program, the Company has not discerned, at this time, an imbalance in the risk benefit profile; however, the clinical holds allow for additional information to be collected to further understand the risk benefit profile of the program.

Patients enrolled in the trials on partial clinical hold who are receiving clinical benefit from treatment as determined by the investigator, may remain on treatment. Patients enrolled in the trial on full clinical hold will be discontinued from treatment. No new patients will be enrolled into the listed trials.

The trials placed on partial clinical hold are:

The trial placed on full clinical hold is:

The trials that will continue to enroll are:

In April 2015, Celgene entered into a strategic collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialize IMFINZI™ for hematologic malignancies. The use of IMFINZI™ in combination with other agents for the treatment of patients with hematologic malignancies is not approved by the FDA, and the safety and efficacy of those combinations have not been established.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

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Celgene Corporation
Patrick E. Flanigan III, 908-673-9969
Corporate VP, Investor Relations
or
Brian Gill, 908-673-9530
VP, Corporate Communications

Source: Celgene Corporation

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