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HEM/ONC News by Devon Schuyler HEM/ONC News By Devon Schuyler Ixazomib Approved for Use in Myeloma FDA Approves Elotuzumab for Myeloma The US Food and Drug Administration (FDA) approved The FDA approved elotuzumab (Empliciti, Bristol-Myers ixazomib (Ninlaro, Takeda/Millennium) on Novem- Squibb) on November 30 for the treatment of patients ber 20 for use in patients with multiple myeloma who with multiple myeloma who have received 1 to 3 prior have received at least 1 prior treatment. Ixazomib, which medications. The agent is for use in combination with is the first oral proteasome inhibitor, is approved for use lenalidomide and dexamethasone. in combination with lenalidomide (Revlimid, Celgene) Approval of elotuzumab was based on an open-label and dexamethasone. trial of 646 patients with relapsed or refractory multiple Approval of ixazomib was based on the results of an myeloma. Patients were randomly assigned to receive international, double-blind clinical trial of 722 patients lenalidomide/dexamethasone either with or without elotu- with relapsed or refractory multiple myeloma. Patients zumab. Median progression-free survival was significantly were randomly assigned to receive lenalidomide/dexa- longer in the group taking elotuzumab (19.4 months) methasone plus either placebo or ixazomib. Median than in the group not taking elotuzumab (14.9 months). progression-free survival was significantly longer in the In addition, the rate of complete or partial response was ixazomib group (20.6 months) than in the placebo group 78.5% with elotuzumab and 65.5% without elotuzumab. (14.7 months). The most common side effects of elotuzumab are The most common side effects of ixazomib are fatigue, diarrhea, pyrexia, constipation, cough, periph- diarrhea, constipation, thrombocytopenia, peripheral eral neuropathy, nasopharyngitis, upper respiratory tract neuropathy, nausea, peripheral edema, vomiting, and infection, decreased appetite, and pneumonia. back pain. Elotuzumab received breakthrough therapy, priority Ixazomib received priority review and orphan drug review, and orphan drug designations from the FDA. status from the FDA. Necitumumab Approved for Metastatic FDA Approves Daratumumab for Myeloma Squamous Cell NSCLC The FDA approved daratumumab (Darzalex, Janssen) on The FDA approved necitumumab (Portrazza, Lilly) on November 16 for use in patients with multiple myeloma November 24 to treat patients with metastatic squamous who have received at least 3 prior treatments. Daratu- cell non–small cell lung cancer (NSCLC) who have not mumab is the first monoclonal antibody approved to treat received medication for advanced lung cancer. Necitu- multiple myeloma. mumab, a monoclonal antibody that blocks the activity Approval of daratumumab was based on 2 open- of epidermal growth factor receptor, is approved for use in label studies. In the first study, in which 106 patients combination with 2 forms of chemotherapy. received daratumumab, 29% of participants experienced Approval of necitumumab was based on a multicenter, a complete or partial response to treatment; responses open-label clinical study of 1093 people with metastatic lasted an average of 7.4 months. In the second study, squamous cell NSCLC. Patients were randomly assigned in which 42 patients received daratumumab, 36% of to receive gemcitabine and cisplatin either with or without participants experienced a complete or partial response necitumumab. Median overall survival was significantly to treatment. longer in patients taking necitumumab (11.5 months) than The most common side effects of daratumumab in in those not taking necitumumab (9.9 months). these studies were infusion-related reactions, fatigue, nau- In a different trial, which used cisplatin/pemetrexed sea, back pain, fever, and cough. Daratumumab also may (Alimta, Lilly), adding necitumumab did not improve cause lymphopenia, neutropenia, leukopenia, anemia, overall survival in patients with nonsquamous cell NSCLC. and thrombocytopenia. The most common side effects of necitumumab are If a patient taking daratumumab requires a blood skin rash and hypomagnesemia, which can lead to muscle transfusion, the blood bank should be informed that the weakness, seizures, irregular heartbeat, and death. A black patient is taking a drug that may interfere with antibody box warning alerts health care providers to the possibility screening and other tests. of cardiac arrest, sudden death, and hypomagnesemia. 66 Clinical Advances in Hematology & Oncology Volume 14, Issue 1 January 2016 FDA Approves Cooling Cap to Reduce Hair antiangiogenic therapy. Nivolumab, an inhibitor of the pro- Loss From Chemotherapy grammed death 1/programmed death ligand 1 checkpoint, previously was approved for use in melanoma and NSCLC. The FDA has cleared for marketing a scalp-cooling system Approval was based on an open-label study of 821 to reduce chemotherapy-induced hair loss in women with patients with advanced renal cell carcinoma whose disease breast cancer. The cooling system (DigniCap, Dignitana), was refractory to treatment with an antiangiogenic agent. which was cleared on December 8, is the first product of Patients were randomly assigned to receive nivolumab or its type to receive approval. everolimus (Afinitor, Novartis). Median overall survival The computer-controlled system works by circulat- was significantly longer for patients taking nivolumab (25 ing cooled liquid throughout a silicone cap that the months) than for those taking everolimus (19.6 months). patient wears during chemotherapy. The silicone cap is The complete or partial response rate also was higher covered by a second cap, made of neoprene, that holds the among patients taking nivolumab (21.5%) than among cooling cap in place and provides insulation. The device those taking everolimus (3.9%). is designed to cause vasoconstriction in the scalp, limiting The most common side effects of nivolumab in the amount of chemotherapy drug that reaches cells in advanced renal cell carcinoma are asthenic conditions, the hair follicles. It also may reduce the effect of chemo- cough, nausea, rash, dyspnea, diarrhea, constipation, therapy on the hair follicles by slowing cell division. decreased appetite, back pain, and arthralgia. Nivolumab Approval of the system was based on a study of 122 also may cause severe immune-mediated side effects. women with stage I or II breast cancer who were under- Nivolumab received FDA breakthrough therapy des- going treatment of breast cancer with chemotherapy ignation, fast track designation, and priority review status. regimens that have been associated with hair loss, such as those containing paclitaxel or docetaxel. Women were FDA Approves von Willebrand Factor to asked to evaluate their own hair loss based on photo- Treat Episodes of Bleeding graphs taken 3 to 6 months after the final chemotherapy cycle. More than 66% of the patients who used the cool- The FDA approved recombinant von Willebrand factor ing system reported losing less than half their hair. (Vonvendi, Baxalta) on December 8 to treat episodes of The most common side effects of the cooling system bleeding in adults with von Willebrand disease. This is the were headaches, neck and shoulder discomfort, chills, and first recombinant von Willebrand factor to receive FDA pain associated with wearing the system for an extended approval. period. There is a theoretical risk of the chemotherapy Approval was based on 2 clinical trials that included drug missing an isolated group of breast cancer cells in 69 adults with von Willebrand disease. The trials demon- the scalp because of cooling cap use. strated the safety and efficacy of recombinant von Wil- The device was evaluated through the de novo clas- lebrand factor for on-demand treatment and control of sification process. bleeding episodes from a variety of sites in the body. The most common adverse reaction in these trials was Nivolumab Approved for Advanced Renal generalized pruritus. Other possible adverse effects include Cell Carcinoma thromboembolic reactions, hypersensitivity reactions, and the formation of neutralizing antibodies (inhibitors) to von Nivolumab (Opdivo, Bristol-Myers Squibb) received an Willebrand factor and/or factor VIII. expanded indication on November 23 to treat advanced The agent was approved by the FDA as an orphan renal cell carcinoma in patients who have received prior product. Clinical Advances in Hematology & Oncology Volume 14, Issue 1 January 2016 67.
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