FDA Nod For Ipsen, XNCR On Watch, Results MAGNIFY CELG’s R2 Regimen

Today’s Daily Dose brings you news about Celgene’s MAGNIFY study results; FDA approval of Ipsen’s expanded use of Dysport; Genmab getting milestone payment after FDA approves expanded use of Darzalex and encouraging trial results of Xencor’s XmAb5871 in patients with active IgG4-Related Disease.

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Celgene Corp.’s (CELG) phase IIIb study of REVLIMID plus Rituximab (R2) combination therapy in patients with relapsed or refractory marginal zone lymphoma has demonstrated clinical activity across indolent non-Hodgkin lymphomas, marginal zone and follicular histologies, as well as responses in poor risk patient subpopulations including early relapsing patients and patients who were refractory to multiple lines of therapy.

The primary endpoint of the study, dubbed MAGNIFY, is progression-free survival (PFS). Enrollment in the study is ongoing.

According to the Company, at the January 9, 2017 data cut-off, the 1-year PFS for all follicular lymphoma patients was 70%.

Michael Pehl, President, Hematology/Oncology at Celgene said, “As we await data from our late-stage programs, including the phase III AUGMENT and RELEVANCE studies, we hope that the growing volume of evidence for R2 may lead to new options for patients that offer an alternative to traditional cytotoxic chemotherapies.”

CELG closed Friday’s trading at $122.36, up 1.45%.

The FDA has approved Genmab A/S’ (GMXAY.OB) DARZALEX in combination with pomalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma.
DARZALEX was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy.

Last November, the FDA approved DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Genmab licensed DARZALEX to Johnson & Johnson’s (JNJ) subsidiary, Janssen Biotech Inc….

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