NEW DRUG APPROVALS Alectinib for NSCLC The FDA has approved alectinib (Alecensa, Genentech) to treat patients with advanced (metastatic) anaplastic lymphoma kinase (ALK)-positive non– small-cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate, treatment with crizotinib (Xalkori, Pfizer). ALK gene mutations are present in approximately 5% of patients with NSCLC. Alectinib is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading. The safety and efficacy of alectinib were studied in two single-arm clinical trials of patients with metastatic ALK-­positive NSCLC whose disease was no longer controlled by treatment with crizotinib. The participants received alectinib twice daily. In the first study, 38% of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44% of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months. Alectinib may cause serious adverse effects, including liver problems, severe or life-threatening inflammation of the lungs, bradycardia, and severe muscle problems. Treatment with alectinib may cause sunburn when patients are exposed to sunlight. Source: FDA, December 11, 2015

Portrazza for Lung Cancer Necitumumab (Portrazza, Eli Lilly) in combination with two forms of chemotherapy (gemcitabine and cisplatin) has secured FDA approval for the treatment


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of patients with metastatic squamous non–small-cell lung cancer (NSCLC) who have not previously received medications specifically for treating their advanced lung cancer. Necitumumab is a monoclonal antibody that blocks the activity of epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors. The safety and efficacy of necitumumab were evaluated in a randomized, open-label clinical study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without necitumumab. Patients treated with necitumumab plus gemcitabine and cisplatin lived longer on average (11.5 months) compared with those receiving only gemcitabine and cisplatin (9.9 months). Necitumumab was not an effective treatment in patients with nonsquamous NSCLC. Source: FDA, November 24, 2015

Tagrisso for Lung Cancer The FDA has granted accelerated approval for an oral medication to treat patients with advanced non–small-cell lung cancer (NSCLC). Osimertinib (Tagrisso, AstraZeneca) was approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. The FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that osimertinib is known to target. The newly approved version of the test adds the T790M mutation to the clinically relevant mutations detected by the original cobas EGFR Mutation Test (v1), which is marketed by Roche Molecular Systems. Source: FDA, November 13, 2015

Empliciti for Multiple Myeloma Elotuzumab (Empliciti, Bristol-Myers Squibb) has won FDA approval in combination with lenalidomide (Revlimid, Celgene Corp.) and dexamethasone to treat patients with multiple myeloma who have received one to three prior medications. Elotuzumab activates the body’s immune system to attack and kill multiple myeloma cells. The safety and efficacy of elotuzumab were evaluated in a randomized, openlabel study of 646 participants whose multiple myeloma recurred after, or did not respond to, previous treatment. Those taking elotuzumab plus lenalidomide and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared with participants taking only lenalidomide and dexamethasone (14.9 months). In addition, 78.5% of those taking elotuzumab with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumors, compared with 65.5% of those taking lenalidomide and dexamethasone. Source: FDA, November 30, 2015

Ninlaro for Multiple Myeloma The FDA has granted approval for ixazomib (Ninlaro, Takeda), used in combination with lenalidomide (Revlimid, Celgene Corp.) and dexamethasone, to treat people with multiple myeloma who have received at least one prior therapy. Ixazomib is a proteasome inhibitor that blocks enzymes from multiple myeloma cells, inhibiting their ability to grow and survive. The safety and efficacy of ixazomib were demonstrated in an international, randomized, double-blind clinical study of 722 patients with multiple myeloma that recurred after, or did not respond to, previous treatment. The participants received either ixazomib in combination with lenalidomide and dexamethasone or

placebo plus lenalidomide and dexamethasone. Those treated with the ixazomib combination lived longer without disease progression (average, 20.6 months) compared with those receiving the placebo combination (average, 14.7 months). Source: FDA, November 20, 2015

Darzalex for Multiple Myeloma The FDA has given accelerated approval to daratumumab (Darzalex, Janssen Biotech) to treat patients with multiple myeloma who have received at least three prior treatments. Daratumumab was the first monoclonal antibody approved for treating multiple myeloma. Daratumumab injection, given as an infusion, works by helping certain cells in the immune system attack cancer cells. Its safety and efficacy were demonstrated in two open-label studies. In one study involving 106 participants, 29% of the subjects receiving daratumumab experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the second study, which involved 42 participants, 36% of those treated with daratumumab had a complete or partial reduction in their tumor burden. Source: FDA, November 16, 2015

Tafinlar/Mekinist for Melanoma The FDA has approved the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of patients with BRAF V600E/K mutationpositive unresectable or metastatic melanoma, as detected by an FDA-approved test. This is the first targeted therapy combination demonstrating more than two years overall survival in patients with the most aggressive form of skin cancer. Novartis markets both products. In Januar y 2014, the dabrafenib/ trametinib combination received provisional approval for use in patients with BRAF V600E/K mutation-positive

unresectable or metastatic melanoma. This approval was contingent on the results of the phase 3 COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation. Updated results from the COMBI-d trial showed that dabrafenib/trametinib achieved a statistically significant overall survival benefit compared with dabrafenib alone (median, 25.1 months versus 18.7 months, respectively; P = 0.01). The analysis also showed median progression-free survival of 9.3 months compared with 8.8 months in the two treatment groups (P = 0.035). The overall response rates were 66% and 51% for dabrafenib/trametinib and dabrafenib monotherapy, respectively. Source: Novartis, November 20, 2015

Bridion to Reverse Neuromuscular Blockade The FDA has approved sugammadex injection (Bridion, Merck) to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscles. They can be used to paralyze the vocal cords when patients require tracheal intubation; to prevent patients from moving during surgery under general anesthesia; and to prevent the body from breathing automatically when a patient must be placed on a ventilator. The safety and efficacy of sugammadex were evaluated in three phase 3 trials involving 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared with the comparator groups.

The FDA declined to approve sugammadex in 2008, citing concerns about potential allergic reactions and bleeding. Sugammadex was subsequently evaluated in a randomized, double-blind, parallelgroup, repeat-dose trial. Of 299 participants treated with sugammadex, one person experienced an anaphylactic reaction. Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex. Patients should be closely monitored for hemodynamic changes during and after the reversal of neuromuscular blockade. The most common adverse events observed in clinical trials included vomiting, hypotension, pain, headache, and nausea. Sources: FDA and Reuters, December 15, 2015

Kanuma for Lysosomal Acid Lipase Deficiency Sebelipase alfa (Kanuma, Alexion Pharmaceuticals) has secured FDA approval as the first treatment for patients with lysosomal acid lipase (LAL) deficiency. Patients with LAL deficiency (a rare condition also known as Wolman disease and cholesteryl ester storage disease) have no or little LAL enzyme activity. This results in a build-up of fats within the cells of various tissues, which can lead to liver and cardiovascular disease and other complications. Sebelipase provides a recombinant human LAL protein that functions in place of the missing, partially active, or inactive LAL protein in the patient. Treatment is provided via intravenous infusion once weekly in patients with rapidly progressive LAL deficiency presenting in the first six months of life, and once every other week in all other patients. Source: FDA, December 8, 2015

Otiprio for Otitis Media The FDA has approved ciprofloxacin otic suspension (Otiprio, Otonomy, Inc.)

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for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio, a single-dose fluoroquinolone antibacterial agent, is the first product approved by the FDA for this indication. It is given by a physician as a single 0.1-mL (6-mg) intratympanic administration into each affected ear after suctioning of the middle-ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two phase 3 trials, a single intra­ operative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared with tubes alone (P 

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