Celgene Faces Multiple Clinical Holds From FDA

Celgene Corp. (NASDAQ: CELG) received an update from the U.S. Food and Drug Administration (FDA) early on Thursday. Although shares did not dip initially, this action could prove to be problematic for the biotech giant going forward.

The FDA 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.

Overall this decision 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, Celgene has not discerned, at this time, an imbalance in the risk benefit profile. The clinical holds do 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.

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The following trials are being put on partial hold:

• MEDI4736-MM-001: Phase 1B durvalumab in subjects with relapsed and refractory multiple myeloma
• MEDI4736-MM-003: Phase 2 durvalumab and daratumumab in subjects with relapsed and refractory multiple myeloma
• MEDI4736-MM-005: Phase 2 durvalumab and daratumumab in subjects with relapsed and refractory multiple myeloma that have progressed while on current treatment regimen containing daratumumab
• MEDI4736-NHL-001: Phase 1/2 durvalumab in subjects with lymphoma or chronic lymphocytic leukemia
• MEDI4736-DLBCL-001: Phase 2 durvalumab with rituximab in subjects with previously untreated, high risk diffuse large B cell lymphoma

Separately, MEDI4736-MM-002 was put on a full clinical hold. This is a Phase 1b study of durvalumab in combination with lenalidomide with and without low-dose dexamethasone in subjects with newly diagnosed multiple myeloma.

Shares of Celgene were last seen at $141.61, with a consensus analyst price target of $150.17 and a 52-week range of $96.93 to $141.85.

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