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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. in August 2012. Genmab will receive milestone payments totaling $25 million from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label.

Darzalex generated sales of $572 million for Johnson & Johnson last year.

GMXAY.OB closed Friday's trading at $107.80, up 2.78%.

The FDA on Friday expanded the approved use of Ipsen Biopharmaceuticals Inc., an affiliate of Ipsen SA's (IPSEY) Dysport for the treatment of lower limb spasticity in adults.

In July 2015, Dysport was approved for the treatment of upper limb spasticity in adults and a year later was given the FDA nod to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin that the FDA approved for this indication.

"Dysport is currently the only botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower limbs and also for the treatment of lower limb spasticity in children ages two and older," said Cynthia Schwalm, President, North America Commercial Operations, Ipsen.

Sales of Dysport totaled 284.7 million Euros in 2016 compared to 279.5 million Euros in 2015.

IPSEY.OB closed Friday's trading at $33.61, up 3.81%.

Xencor Inc. (XNCR) on Friday reported encouraging data from an ongoing, open-label, pilot phase II study of XmAb5871 in patients with active IgG4-Related Disease.

According to the trial results, 93% of patients achieved a response to therapy, 12 of them within two weeks of their first dose.

John H. Stone, the principal investigator of the study said, "The rapid clinical responses in many patients and the continued decline in the inflammatory response indicate that XmAb5871 is clearly a promising therapy for IgG4-RD. We have learned a lot about how to study this disease in the context of this small trial."

XNCR closed Friday's trading at $20.00, down 3.12%.

by RTTNews Staff Writer

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