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P T. 2016;41(7): 408-412, 415, 422

Drug and Device News July 2016

NEW DRUG APPROVALS

Byvalson for Hypertension

Byvalson (nebivolol/valsartan, Allergan) 5 mg/80 mg tablets have won FDA approval for the treatment of patients with hypertension to lower blood pressure. Byvalson is the first fixed-dose combination (FDC) of a beta blocker and an angiotensin II-receptor blocker available in the United States.

The FDA’s decision was based on positive data from a phase 3, double-blind, placebo-controlled, dose-escalating efficacy and safety study, which enrolled approximately 4,100 patients with stage 1 or 2 hypertension. Treatment with the FDC of nebivolol and valsartan for four weeks demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure compared with either nebivolol alone or valsartan alone.

Source: Allergan, June 6, 2016

Jentadueto XR for Diabetes

The FDA has approved Jentadueto XR (2.5 mg or 5.0 mg linagliptin and 1,000 mg metformin hydro chloride extended-release tablets, Boehringer Ingelheim/Lilly) for the treatment of type-2 diabetes in adults.

Linagliptin works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose. Metformin lowers glucose production by the liver and its absorption in the intestine.

Jentadueto XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes when treatment with both linagliptin and metformin is appropriate.

Source: Eli Lilly, May 31, 2016

Zinbryta for Multiple Sclerosis

Daclizumab (Zinbryta, Biogen) has received FDA approval for the treatment of adults with relapsing forms of multiple sclerosis. Daclizumab is a once-monthly, long-acting injection that is self-administered by the patient.

A boxed warning advises that the drug can cause severe liver injury, including life-threatening and fatal events, and highlights other important risks of daclizumab treatment, including immune conditions, such as noninfectious colitis, skin re actions, and lymphadenopathy.

Source: FDA, May 27, 2016

Ocaliva for Biliary Cholangitis

The FDA has granted accelerated approval to obeticholic acid (Ocaliva, Intercept Pharmaceuticals) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid and inflammatory, fibrotic, and metabolic pathways.

The approval was based on a reduction in alkaline phosphatase. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon the verification of a clinical benefit in confirmatory trials.

Source: Intercept Pharmaceuticals, May 27, 2016

Probuphine for Opioid Dependence

The FDA has approved Probuphine (Titan Pharmaceuticals/Braeburn Pharma ceuticals), the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program. Previously, buprenorphine was approved for the treatment of opioid dependence only as a pill or buccal film.

Probuphine consists of four 1-inch-long rods that are implanted under the skin on the inside of the upper arm. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring post-marketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.

Source: FDA, May 26, 2016

Afstyla for Hemophilia A

The FDA has granted approval to CSL Behring for the manufacture and marketing of Afstyla (antihemophilic factor [recombinant], single chain), a recombinant factor VIII single-chain therapy for adults and children with hemophilia A. It is the first single-chain product for hemophilia A specifically designed for long-lasting protection from bleeds with dosing two or three times a week.

In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate of 0.00. Once activated, Afstyla is identical to natural factor VIII. The treatment is indicated in adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; for on-demand treatment and control of bleeding episodes; and for the perioperative management of bleeding. It is expected to be available in the summer of 2016.

Source: CSL Behring, May 26, 2016

Flucelvax Quadrivalent Vaccine

Flucelvax Quadrivalent (influenza vaccine, Seqirus), the first four-strain, cell-culture-derived, inactivated seasonal influenza vaccine for people 4 years of age and older, has been approved by the FDA. The vaccine helps protect against the two influenza A viruses and two influenza B viruses that are indicated by the World Health Organization and the FDA as significant for the 2016–2017 flu season.

Flucelvax Quadrivalent is produced using the same cell-culture manufacturing technology as its predecessor, Flucelvax, a trivalent influenza vaccine. Because the two vaccines have overlapping compositions, the clinical efficacy and safety data from clinical trials of Flucelvax are relevant to Flucelvax Quadrivalent.

Source: Seqirus, May 23, 2016

Tecentriq for Bladder Cancer

The FDA has approved atezolizumab (Tecentriq, Genentech) for the treatment of patients with urothelial carcinoma, the most common type of bladder cancer. It is the first product in its class (programmed death-1/programmed death ligand-1 [PD-1/PD-L1] inhibitors) approved to treat this type of cancer.

Atezolizumab is approved for patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or after platinum-containing chemotherapy, or within 12 months after receiving platinum-containing chemotherapy, either before or after surgical treatment.

Atezolizumab targets the PD-1/PD-L1 pathway (proteins found in immune cells and in some cancer cells). By blocking these interactions, the drug may help the body’s immune system fight cancer cells.

Source: Genentech, May 18, 2016

Generic Approvals

Voriconazole Tablets

Novel Laboratories, Appco Pharma, Ajanta Pharma, and Zydus Pharmaceuticals have received FDA approval to market their respective versions of generic voriconazole oral tablets (50 mg and 200 mg). Voriconazole, an azole anti-fungal drug, was initially approved by the FDA in 2002 under the brand name Vfend (Pfizer/Roerig). Vfend tablets are indicated for the treatment of invasive aspergillosis; candidemia (non neutropenics) and disseminated candidiasis in the skin, abdomen, kidney, bladder wall, and wounds; esophageal candidiasis; and serious infections caused by Scedosporium apiospermum and Fusarium species, including F. solani, in patients intolerant of or refractory to other therapy.

Sources: FDA, May 24, 2016, and Vfend prescribing information

Mibelas 24 Fe

The FDA has granted approval to Lupin Atlantis to market Mibelas 24 Fe, the first generic version of Minastrin 24 Fe (Actavis Pharma), a low-dose estrogen/progestin combination oral contraceptive (COC). The tablets are blister-packed in the order in which they are taken. Each 28-day package contains 24 active tablets each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol and four placebo tablets each containing 75 mg ferrous fumarate. As with all COCs, a boxed warning advises that cigarette smoking increases the risk of serious cardiovascular events from COC use. Ethinyl estradiol/norethindrone acetate tablets were approved by the FDA in 1968 under the brand name Lo Loestrin Fe (Warner Chilcott Company).

Source: FDA, May 24, 2016, and Minastrin 24 Fe prescribing information

NEW INDICATIONS

Teflaro for Pediatric Patients

The FDA has approved a supplemental new drug application for ceftaroline fosamil (Teflaro, Allergan), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin-structure infections (ABSSSIs), including infections caused by methicillin-resistant Staphylococcus aureus and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.

Ceftaroline is a bactericidal cephalosporin with activity against both gram-positive and gram-negative pathogens. It was first approved by the FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens.

Source: Allergan, May 31, 2016

Invokamet for Diabetes

Invokamet (Janssen), a fixed-dose combination therapy consisting of canagliflozin (Invokana) and metformin hydrochloride, has been approved by the FDA for first-line treatment of adults with type-2 diabetes. Invokamet may now be prescribed to adults with type-2 diabetes who are not already being treated with canagliflozin or metformin and who may benefit from dual therapy.

Invokamet, the first combination of a sodium-glucose cotransporter-2 inhibitor and metformin available in the U.S., was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes not adequately controlled by either canagliflozin or metformin, or who are already being treated with both medications separately.

Source: Janssen, May 24, 2016

Lenvima for Renal Cell Carcinoma

The FDA has approved lenvatinib (Lenvima, Eisai, Inc.), a multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) who were previously treated with an antiangiogenic therapy. The agency’s decision was based on positive results from a phase 2 registration study in which the once-daily combination of lenvatinib 18 mg and everolimus 5 mg demonstrated a substantial improvement in progression-free survival, objective response rate, and overall survival compared with everolimus alone—a standard of care for patients with advanced RCC who have received prior antiangiogenic therapy.

Lenvatinib was first approved in the U.S. in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory, differentiated thyroid cancer.

Source: Eisai, Inc., May 16, 2016

FDA REVIEW ACTIVITIES

Breakthrough Therapy Status

Vyxeos for Blood Cancers

An FDA breakthrough therapy designation has been awarded to Vyxeos (cytarabine:daunorubicin, Celator Pharmaceuticals), an investigational product in development as a treatment for acute myeloid leukemia (AML) and other blood cancers. The designation was primarily based on positive results from a pivotal phase 3 trial in older patients with previously untreated high-risk (secondary) AML. The median overall survival for patients treated with Vyxeos was 9.56 months compared with 5.95 months for patients receiving the “7+3” combination regimen of cytarabine and daunorubicin, the standard of care for AML. This represents a 3.61-month improvement in favor of Vyxeos.

Source: Celator Pharmaceuticals, May 19, 2016

Fast-Track Designations

VT-1129 for Cryptococcal Meningitis

A fast-track designation has been granted by the FDA for VT-1129 (Viamet Pharmaceuticals) for the treatment of cryptococcal meningitis, a life-threatening fungal infection of the membranes covering the brain and spinal cord. VT-1129, an orally available inhibitor of fungal sterol 14 alpha-demethylase, has also received an orphan drug designation for the treatment of cryptococcal meningitis and has been designated a qualified infectious disease product by the FDA.

Source: Viamet Pharmaceuticals, June 1, 2016

Orphan Drug Designations

d-Methadone for Shingles

d-Methadone (dextromethadone, REL-1017, Relmada Therapeutics), an N-methyl-d-aspartate (NMDA) receptor antagonist in development as a treatment for both depression and chronic neuropathic pain, has received an orphan drug designation from the FDA for the management of postherpetic neuralgia (PHN), a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles.

As a single isomer, d-Methadone has been shown to have NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA receptors has been associated with neuropathic pain, and it is expected that d-Methadone will have a role in pain management by blocking this activity.

Source: Relmada Therapeutics, June 7, 2016

Debio 1143 for Ovarian Cancer

The FDA has granted orphan drug status to Debio 1143 (Debiopharm International) for the treatment of ovarian cancer. Debio 1143 is an oral, small-molecule inhibitor of inhibitors of apoptosis proteins with a dual proapoptotic and immunomodulatory mode of action developed as a chemo/radiosensitizer in oncology.

Source: Debiopharm International, June 2, 2016

SUBA-Itraconazole for BCCNS

SUBA-Itraconazole (HedgePath Pharmaceuticals) has received an FDA orphan drug designation for the treatment of patients with basal cell carcinoma nevus syndrome (BCCNS).

SUBA-Itraconazole is a proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble. SUBA-Itraconazole oral capsules were developed to improve absorption and significantly reduce variability compared with generic itraconazole.

Source: HedgePath Pharmaceuticals, June 2, 2016

RT001 for Friedreich’s Ataxia

FDA orphan drug status has been granted to RT001 (Retrotope, Inc.) for the treatment of patients with Friedreich’s ataxia (FA). The decision followed an announcement that RT001 was well tolerated, with no serious adverse events or dose-limiting toxicities, in the first cohort of a phase 1/2 clinical trial in FA patients.

RT001 is a chemically stabilized form of a natural fatty acid that confers resistance to lipid peroxidation in mitochondrial and cellular membranes.

FA is a debilitating, life-shortening neurodegenerative disorder that affects approximately 5,000 people in the United States, and more than 20,000 people worldwide. A progressive loss of coordination and muscle strength leads to motor incapacitation, the full-time use of a wheelchair, and ultimately early death, typically from cardiomyopathy. There is no approved treatment for FA.

Source: Retrotope, Inc., June 1, 2016

Advisory Committee Action

Abuse-Deterrent Opioid Vantrela ER

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted 14 to three to recommend approval of Vantrela ER (Teva Pharmaceuticals) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Vantrela ER is an extended-release formulation of hydrocodone bitartrate with Teva’s proprietary abuse-deterrence technology.

The committees also voted that, if approved, Vantrela ER should be labeled as an abuse-deterrent product by the oral, nasal, and intravenous routes of abuse.

Source: Teva Pharmaceuticals, June 7, 2016

DRUG SAFETY ISSUES

Serious Heart Problems With High-Dose Imodium

The FDA has warned that taking higher-than-recommended doses of the common over-the-counter (OTC) and prescription antidiarrheal medication loperamide (Imodium) can cause serious heart problems, including abnormal heart rhythms that can lead to death. The risk of these heart problems may also be increased when high doses of loperamide are taken with several kinds of medications that interact with loperamide.

Most of the reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.

The maximum approved daily dose for adults is 8 mg for OTC use and 16 mg for prescription use. Loperamide is sold under the OTC brand name Imodium A–D (Johnson & Johnson) and as store brands and generics.

Source: FDA, June 7, 2016

Serious Bleeding Risk With OTC Antacids Containing Aspirin

The FDA has issued a warning of the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. Aspirin-containing antacids already have warnings about this bleeding risk on their labels; however, the FDA is continuing to receive reports of this serious safety issue.

Source: FDA, June 6, 2016

Burns and Scarring With Zecuity Migraine Patch

Teva Pharmaceutical Industries has announced that it will voluntarily suspend sales, marketing, and distribution of Zecuity (sumatriptan iontophoretic transdermal system). Teva has received post-marketing reports of application site burns and scars in patients treated with Zecuity, and is working in full cooperation with the FDA to investigate these adverse events. Teva has also initiated a pharmacy-level recall of the product and advised patients to discontinue use.

Zecuity delivers sumatriptan through the skin using iontophoresis, a noninvasive method of delivering a drug through the skin using a low electrical current. The Zecuity electronics, powered by two coin-cell lithium batteries, control the amount of current applied and the rate and amount of sumatriptan delivered.

Source: FDA, June 2, 2016, and Teva, June 13, 2016

Canagliflozin and Risk of Leg and Foot Amputations

The FDA says interim safety results from the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medication canagliflozin (Invokana, Invokamet, Janssen). The agency has not determined whether canagliflozin increases the risk of leg and foot amputations. It is investigating this issue.

An interim analysis showed that over one year, the risks of amputation for patients in the CANVAS trial were equivalent to seven of every 1,000 patients treated with 100 mg daily of canagliflozin; five of every 1,000 patients treated with 300 mg daily of canagliflozin; and three of every 1,000 patients given placebo.

Canagliflozin is used with diet and exercise to lower blood sugar in adults with type-2 diabetes. It belongs to a class of drugs called sodium-glucose co transporter-2 inhibitors.

Source: FDA, May 18, 2016

CLINICAL TRIALS UPDATE

Efficacy and Safety Results

Sirukumab for RA

A pivotal global phase 3 study investigating subcutaneous sirukumab (GlaxoSmithKline/Janssen Biologics), a human anti-interleukin-6 monoclonal antibody, in adults with moderately to severely active rheumatoid arthritis (RA) has met both coprimary endpoints. The SIRROUND-D trial enrolled RA patients who had an inadequate response to treatment with disease-modifying antirheumatic drugs.

The results showed that inhibition of radiographic progression, or joint destruction, was significantly greater among sirukumab-treated patients, with a mean change from baseline to week 52 in the van der Heijde–Sharp score of 0.50 among patients receiving sirukumab 50 mg every four weeks (n = 557) and 0.46 for patients receiving sirukumab 100 mg every two weeks (n = 557) compared with 3.69 in the placebo group (n = 556). Significant inhibition of radiographic progression was demonstrated in patients naïve to biologic therapy and those treated with biologics in the past, and was seen as early as week 24.

Source: GlaxoSmithKline, June 8, 2016

Xeljanz for Psoriatic Arthritis

Pfizer has reported positive results from the second phase 3 study of tofacitinib citrate (Xeljanz), a Janus kinase inhibitor, in patients with active psoriatic arthritis (PsA). The six-month, randomized, double-blind, placebo-controlled OPAL trial investigated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily in patients with active PsA who had an inadequate response to at least one tumor necrosis factor inhibitor because of lack of efficacy or an adverse event.

The study met its primary efficacy endpoints, demonstrating a statistically significant improvement with both dosages of tofacitinib compared with placebo, as measured by the American College of Rheumatology 20 response (a 20% improvement) and the Health Assessment Questionnaire Disability Index score at three months.

Source: Pfizer, June 7, 2016

Imbruvica for Leukemia/Lymphoma

Positive longer-term follow-up results have been reported from phase 3 studies of ibrutinib (Imbruvica, Pharmacyclics/Janssen Biotech) in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL). The findings included an analysis of outcomes from the RESONATE and RESONATE-2 trials, which showed that ibrutinib was associated with favorable progression-free survival and overall survival, whether patients were previously treated or treatment-naïve.

Longer-term follow-up results from the HELIOS trial showed that ibrutinib in combination with bendamustine and rituximab (BR) continued to demonstrate superiority over time compared with placebo plus BR in patients with relapsed/refractory CLL/SLL, along with improvements in the quality of response.

Source: AbbVie, June 6, 2016

Buprenorphine Buccal Film for Pain

New data have supported the safety and tolerability of Belbuca (buprenorphine) buccal film (Endo Pharmaceuticals) for the long-term management of chronic pain in patients requiring around-the-clock opioids. A phase 3, open-label study enrolled 506 patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid treatment. Adverse events occurred in 43% and 54% of patients during the titration (n = 506) and long-term treatment (n = 435) phases, respectively. The most common adverse events included nausea (10%), constipation (6%), and headache (4%) during the titration phase, and nausea (8%), vomiting (5%), and upper respiratory tract infection (5%) during long-term treatment. The FDA approved Belbuca in October 2015.

Source: Endo Pharmaceuticals, June 3, 2016

Plinabulin/Docetaxel for NSCLC

Docetaxel is approved for use in patients with non–small-cell lung cancer (NSCLC) after the failure of first-line chemotherapy, but the treatment has an unfavorable toxicity profile that limits its use. An investigational therapy, plinabulin (BeyondSpring Pharmaceuticals), is being developed in combination with docetaxel to provide a regimen with an improved safety profile. Plinabulin is a vascular-disruptive agent with immuno-oncology effects.

In a phase 2 study, plinabulin/docetaxel provided a significant duration-of-response benefit over docetaxel alone (12.7 months versus 1.5 months, respectively; P < 0.05). The combination mitigated some of the toxicities of docetaxel monotherapy. Plinabulin/docetaxel provided significant reductions in grade-3 or grade-4 neutropenia (7% versus 25%) and in asthenia (13% versus 28%); significantly reduced the use of granulocyte-colony stimulating factor (14% versus 29%); and significantly reduced docetaxel dose reductions due to toxicity (6% versus 20%).

Source: BeyondSpring Pharmaceuticals, May 26, 2016

Secnidazole for Bacterial Vaginosis

Positive results have been reported from the second pivotal trial of oral secnidazole (SYM-1219, Symbiomix Therapeutics) for the treatment of bacterial vaginosis (BV). Secnidazole is a next-generation 5-nitroimidazole antibiotic.

The phase 3, randomized, double-blind, placebo-controlled trial compared a single oral dose of secnidazole with placebo in 189 women with infrequent or recurrent BV. Secnidazole achieved statistically and clinically significant results across all primary and secondary endpoints.

Source: Symbiomix Therapeutics, May 26, 2016

Xaracoll for Postoperative Pain

Two placebo-controlled phase 3 pivotal studies evaluating Xaracoll (bupivacaine-collagen bioresorbable implant, Innocoll Holdings) have achieved their primary endpoints, demonstrating post operative pain relief immediately after open abdominal hernia repair. Xaracoll showed consistency across both studies in its treatment effect for both pain reduction and opioid reduction.

The primary efficacy endpoint—the sum of pain intensity over 24 hours for Xaracoll compared with placebo—met statistical significance in both the MATRIX-1 (P = 0.0004) and MATRIX-2 (P < 0.0001) studies. A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours. Pooled data from the two MATRIX studies were statistically significant for this endpoint (P = 0.0033).

Source: Innocoll Holdings, May 25, 2016

Ibalizumab for Drug-Resistant HIV-1

Preliminary results have been reported from a 24-week phase 3 trial of ibalizumab (Thera technologies, Inc.) in patients with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection. The findings indicate that 83% of patients enrolled in the study (33/40; P < 0.0001) met the primary endpoint of a decrease of 0.5 log10 or more in viral load after seven days of treatment with ibalizumab.

Ibalizumab is the first humanized monoclonal antibody in clinical trials for the treatment of patients with HIV-1 infection. The antibody is a novel CD4-directed HIV entry-inhibitor.

Source: Theratechnologies, Inc., May 24, 2016

Ustekinumab for Crohn’s Disease

New phase 3 data have shown that a significantly greater proportion of adults with moderate-to-severe Crohn’s disease receiving subcutaneous (SC) maintenance therapy with the biologic agent ustekinumab (Stelara, Janssen) were in clinical remission at one year compared with placebo-treated patients.

In the IM-UNITI trial, 53% of patients receiving a 90-mg SC injection of ustekinumab every eight weeks and 49% of patients receiving a 90-mg SC injection of ustekinumab every 12 weeks were in clinical remission at week 44 (the study’s primary endpoint), compared with 36% of patients receiving placebo.

Ustekinumab is approved in the U.S. for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, or for adults with active psoriatic arthritis. An application seeking approval of ustekinumab for the treatment of patients with moderate-to-severe active Crohn’s disease is under FDA review.

Source: Janssen, May 23, 2016

Opdivo for NSCLC

Two-year overall survival data have been reported from two pivotal phase 3 studies of nivolumab (Opdivo, Bristol-Myers Squibb) versus docetaxel in previously treated patients with metastatic non–small-cell lung cancer (NSCLC). In the CheckMate-057 trial, 29% (81/292) of previously treated patients with non-squamous NSCLC given nivolumab were alive at two years compared with 16% (45/290) of those treated with docetaxel. In the CheckMate-017 trial, 23% (29/135) of previously treated patients with squamous NSCLC given nivolumab were alive at two years compared with 8% (11/137) of those treated with docetaxel. In the Checkmate-057 and Checkmate-017 trials, treatment-related adverse events occurred in 71% and 61% of nivolumab-treated patients, respectively.

Source: Bristol-Myers Squibb, May 19, 2016

DEVICE APPROVALS

Cerêve Sleep System

The FDA has granted commercial clearance for the Cerêve sleep system, a prescription device that reduces latency to stage-1 and stage-2 sleep for people with insomnia.

Functional brain imaging studies showed that the frontal cortex stays active in people with insomnia during sleep, preventing them from getting deeper, more restorative sleep. The Cerêve system cools the forehead within a clinically proven therapeutic range to reduce this activity in the frontal cortex. The FDA evaluated the company’s application under a de novo classification for novel, low-risk devices.

Source: Cerêve, June 6, 2016

First Blood Test to Detect NSCLC Gene Mutations

The FDA has given the green light to the cobas EGFR [epidermal growth factor receptor] Mutation Test v2 (Roche Molecular Systems), a blood-based companion diagnostic for the cancer drug erlotinib (Tarceva, Astellas Pharma Technologies/Genentech). This is the first FDA-approved, blood-based genetic test that can detect EGFR gene mutations in patients with non–small-cell lung cancer (NSCLC). With the test, the presence of specific NSCLC mutations—exon 19 deletion or exon 21 substitution mutations—detected in patients’ blood samples aids in selecting those who may benefit from erlotinib.

Source: FDA, June 1, 2016

CMV Test for Stem Cell Transplant Recipients

The FDA has approved the COBAS AmpliPrep/COBAS TaqMan CMV [cytomegalovirus] Test (Roche Molecular Systems), the first CMV test for use in hematopoietic stem cell transplant recipients. The standardized real-time polymerase chain reaction-based CMV test is designed for use on the automated COBAS AmpliPrep/COBAS Taq-Man System, an established platform for viral load monitoring of multiple infectious diseases. The in vitro nucleic acid amplification test provides quantitative measurement of CMV DNA.

Source: Roche, May 25, 2016

OTHER DEVICE NEWS

Wearable Artificial Kidney

A prototype of a wearable artificial kidney was recently tested on seven patients at the University of Washington Medical Center in Seattle. The study was led by the device’s inventor, Victor Gura, MD, of Cedars–Sinai Medical Center in Los Angeles. The trial was designed to see how well the wearable kidney might work to safely take over some of the functions of failed kidneys. Patients used the device for up to 24 hours.

The device successfully cleared the blood of urea, creatinine, and phosphorus, and also helped rid the blood of excess water and salt. Patients seemed to tolerate the therapy well, with no effect on circulation and no serious adverse effects, the researchers found. Some redesigns are needed to correct device-related technical problems that occurred during testing.

Source: University of Washington Health Sciences, June 2, 2016

Breathalyzer Detects Lung Cancer

A breathalyzer device designed to detect the early signs of lung cancer is being tested at several British hospitals, with the aim of having the noninvasive technology in clinics in 2017.

Cambridge-based Owlstone Medical has developed microchip sensor technology to measure volatile organic compounds in patients’ exhaled breath. The technology was originally developed to detect explosives and toxic gases but was reprogrammed to identify the chemical markers of diseases, with a lung cancer breathalyzer the first to reach clinical trials.

The breathalyzer device can detect and identify multiple chemicals in a gas flow at very low concentrations, typically parts per billion. Patients wear a breathalyzer mask and breathe normally for several minutes while the sample is collected.

Source: Reuters, May 19, 2016

Blood Test for Colon Cancer

Polymedco has launched Epi proColon, a newly approved blood test for colorectal cancer screening in patients who are noncompliant with screening and are unwilling or unable to complete both fecal immunochemical testing and colonoscopy. It is the first approved molecular DNA blood test for colorectal cancer screening.

Epi proColon detects cell-free tumor DNA circulating in blood. The proprietary Septin 9 gene methylation biomarker is extracted from plasma by enhanced sensitive nucleic acid isolation and undergoes bisulfite conversion, real-time polymerase chain reaction, and analysis.

Source: Polymedco, May 16, 2016

Blood-Transfer Device Recalled

Hummingbird Med Devices Inc. has recalled certain lots of the Hummi Micro-Draw Blood Transfer Device because the Y-shaped connector and the yellow tube may disconnect from each other before or during use. This could lead to blood or fluid leakage.

The device connects to a catheter to collect small-volume blood samples from infants. The collected blood is transferred from the device to a syringe or other container for transport and processing. The device is primarily used in hospitals.

Source: FDA, May 26, 2016