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FDA Approves Empliciti & Ninlaro for Multiple Myeloma

doi: 10.1097/01.COT.0000479766.00548.56
FDA Updates
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The Food and Drug Administration has approved Empliciti (elotuzumab) for use in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior medications.

Also newly approved is Ninlaro (ixazomib) for use in combination with two other therapies to treat patients with multiple myeloma who have received at least one prior therapy.

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Empliciti

Empliciti, marketed by Bristol-Myers Squibb, is an investigational monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and natural killer cells, but not detectable in normal tissue.

“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release.

Empliciti previously received Priority Review designation for this indication (OT 10/25/15 issue), as well as Breakthrough Therapy and Orphan Drug designations.

Safety and efficacy for this indication were tested in a randomized, open-label clinical study of 646 patients with multiple myeloma that had relapsed or did not respond to previous treatment. Patients who received a combination of Empliciti, Revlimid, and dexamethasone had a progression-free survival time of 19.4 months compared with 14.9 months for patients taking only Revlimid and dexamethasone.

And, 78.5 percent of the patients receiving Empliciti with Revlimid and dexamethasone saw a complete or partial shrinkage of their tumors compared with 65.5 percent of those receiving only Revlimid and dexamethasone. The most common side effects reported by patients receiving Empliciti were fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.

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Ninlaro

Ninlaro, a once-weekly pill, is a proteasome inhibitor that works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive. The drug is the first oral proteasome inhibitor approved for the treatment of patients with multiple myeloma, and it is approved in combination with another FDA-approved treatment for multiple myeloma, Revlimid (lenalidomide), and dexamethasone

“The approval is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed,” Pazdur said.

The FDA also recently approved the use of Darzalex (daratumumab) for the treatment of patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent; and the FDA has recently approved Farydak (panobinostat) for the treatment of patients with multiple myeloma who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent (OT 3/25/15 issue).

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‘Watershed Moment’

“The field of cancer treatment, and multiple myeloma in particular, has never seen a watershed moment like this,” Walter M. Capone, President and CEO of the Multiple Myeloma Research Foundation, said in a statement. “The transformation of the treatment of myeloma is clearly underway.”

Ninlaro, marketed by Takeda Pharmaceuticals, had previously received Priority Review status for this myeloma indication (OT 10/25/15 issue).

The safety and efficacy were evaluated in the international, randomized, double-blind TOURMALINE-MM1 clinical trial of 722 patients whose myeloma relapsed or did not respond to previous treatment.

Patients received either Ninlaro in combination with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. Those receiving Ninlaro lived longer without their disease worsening (20.6 months on average) compared with patients receiving the combination therapy plus placebo (14.7 months on average).

The most common side effects reported for patients receiving Ninlaro were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions were thrombocytopenia and diarrhea.

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Clinical Quick Facts: Ninlaro

Drug: Ninlaro (ixazomib)

Approved Indication: Use in combination with two other therapies to treat patients with multiple myeloma who have received at least one prior therapy

Serious Side Effects: Thrombocytopenia and diarrhea

Common Side Effects: Diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain

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Clinical Quick Facts: Empliciti

Drug: Empliciti (elotuzumab)

Approved Indication: In combination with Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid) for the treatment of patients with multiple myeloma who have received one to three prior medications

Common Side Effects: Fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia

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