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Monthly News Roundup - July 2017

FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes

The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of two types: either genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor regimen, or genotype 1a or 4 previously treated with a sofosbuvir regimen without an NS5A inhibitor. Vosevi, given once daily, is used in patients without cirrhosis or with compensated cirrhosis who failed other HCV treatments. In studies, 96 to 97 percent of patients who received Vosevi had no virus detected 12 weeks after finishing treatment. Common side effects include headache, fatigue, diarrhea, and nausea.

Nerlynx Cleared To Lower Risk of Breast Cancer Recurrence

The FDA has given clearance Puma Biotechnology’s Nerlynx (neratinib), a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of early stage HER2-positive breast cancer, following adjuvant trastuzumab (Herceptin) based therapy. Nerlynx is the first extended adjuvant therapy to further lower this type of breast cancer recurrence. In clinical studies after two years, 94.2% of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9% percent of patients receiving placebo. Common side effects include diarrhea, nausea, abdominal pain, fatigue, and vomiting, among others. Patients should be given loperamide for the first 56 days of treatment, then as needed, to help manage diarrhea with Nerlynx.

FDA Approves Endari for Sickle Cell Disease

Sickle cell disease is an inherited disorder which leads to crescent, or "sickle" shaped red blood cells that limit oxygen delivery and leads to severe pain and organ damage. The FDA has now approved oral Endari (L-glutamine), an amino acid formulation to relieve pain, swelling and other complications of sickle cell disease. In clinical studies of Endari compared to placebo over 48 weeks, patients who received Endari had fewer hospital visits for pain due to sickle cell crisis (median 3 vs. 4), fewer hospital days (median 6.5 days vs. 11 days), and fewer occurrences of life-threatening acute chest syndrome (8.6% vs. 23.1%). Common side effects of Endari include constipation, nausea, headache, and stomach pain, among others.

Janssen’s Tremfya Gains Approval for Treatment of Plaque Psoriasis

Janssen’s Tremfya (guselkumab), a first-in-class interleukin-23 blocker, has been FDA-approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is given as a 100 mg subcutaneous injection. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in itching, pain, stinging, burning and skin tightness when compared with placebo at week 16. Superior results in skin clearance compared with Humira (adalimumab) were shown at weeks 16, 24 and 48. Common side effects may include respiratory infections, headache, injection site reactions, and joint pain, among others.

Blincyto Granted Full Approval for Advanced Acute Lymphoblastic Leukemia

Amgen’s Blincyto (blinatumomab), previously approved on an "accelerated" basis by the FDA, has received full FDA approval of their supplemental Biologics License Application (sBLA) to include overall survival (OS) data from the Phase 3 TOWER study. Blincyto is a bispecific CD19-directed CD3 T-cell engager. The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the TOWER study, Blincyto nearly doubled median overall survival (OS) compared to standard of care (SOC) treatments. Median OS was 7.7 months (95 percent CI: 5.6, 9.6) for Blincyto versus 4 months (95 percent CI: 2.9, 5.3) for SOC treatments.

GSK’s Benlysta is First Subcutaneous, Self-Injectable Lupus Drug

Systemic Lupus Erythematosus (SLE) affects 170,000-200,000 Americans and is the most common form of lupus, a chronic, incurable autoimmune disease that attacks body systems. In response, the FDA has approved a subcutaneous (injected under the skin) form of Benlysta (belimumab) for adults with active, autoantibody‑positive SLE who are receiving standard therapy. Benlysta is a B-lymphocyte stimulator (BLyS)-specific inhibitor and the only medication specifically approved for SLE. Approval for Benlysta was based on 52-week pivotal studies of more than 800 patients with active SLE, which measured reduction in disease activity assessed by SRI, a composite measure of efficacy in lupus.

Yervoy Use Now Includes Kids 12 Years and Older with Metastatic Melanoma

Metastatic melanoma in children is very rare, and treatment options are limited. The FDA has expanded the approved indications for Yervoy (ipilimumab) injection to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two studies; the first, a dose-finding study, and the second, an open-label, single-arm trial. Of the 17 patients 12 years and older with melanoma treated with Yervoy across both studies, two patients experienced objective responses, including one partial response that was sustained for 16 months. The overall safety profile of Yervoy in children and adolescents was consistent with the safety profile in adults.

Posted: July 2017