Skip to Content

Weekly Drug News Round-Up: September 27, 2017

Xhance Nasal Spray Approved for the Treatment of Nasal Polyps

It is estimated that up to 10 million Americans suffer from nasal polyps Read More...

Corticosteroids like fluticasone address the inflammation that can occur with nasal polyps. Now, the FDA has approved Xhance (fluticasone propionate) for nasal polyp treatment in patients 18 years of age and older. In Phase 3 studies, patients in both the Xhance 186 and 372 mcg twice daily groups achieved statistically significant reductions in both outcome measures: congestion/obstruction at week 4 and total polyp grade at week 16. Common side effects in trials included epistaxis (nose bleeds), nasal septal ulceration, and headache, among others. Xhance will be available commercially in the second quarter of 2018, and delivers the medicine with an innovative new approach, called an Exhalation Delivery System (EDS).

Merck’s Keytruda Gains Accelerated Approval for Advanced Gastric Cancer

Among the 19 responding patients, the duration of response ranged from 2.8+ to 19.4+ months Read More...

Keytruda (pembrolizumab) from Merck has been approved for the treatment of recurrent locally advanced or metastatic gastric cancer (stomach cancer) or gastroesophageal junction (GEJ) cancer whose tumors express PD-L1. Eligible patients have had disease progression on or after two or more regimens including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy. In the KEYNOTE-59 clinical trials patients received Keytruda 200 mg every three weeks until unacceptable toxicity or disease progression. For 143 patients, the objective response rate (ORR) was 13.3 percent (95% CI: 8.2, 20.0) – with a complete response rate of 1.4 percent and a partial response rate of 11.9 percent. Visit here to learn more about checkpoint inhibitors like Keytruda.

Bristol-Myers Squibb’s Opdivo Gets Accelerated Clearance for Liver Cancer

Hepatocellular carcinoma is often diagnosed in the advanced-stage where treatment options are limited Read More...

The death rates for liver cancer are increasing at a faster pace than any other cancer, doubling since the mid-1980s, and many patients are not candidates for surgery. In response, this week the FDA approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with hepatocellular carcinoma (liver cancer) who have been previously treated with Nexavar (sorafenib). In the CheckMate-040 trial, 14.3% (22/154) of patients had a response to Opdivo, with 1.9% having a complete response and 12.3% with a partial response. Responses ranged from 3.2 to 38.2+ months; 91% of patients had responses of six months or longer and 55% had responses of 12 months or longer.

BioCryst's Rapivab Receives FDA Approval for Pediatric Influenza

One-time dosing and an intravenous formulation for patients who cannot tolerate oral medicines are advantages to Rapivab Read More...

Rapivab (peramivir) is an intravenous (IV) viral neuraminidase inhibitor used for the treatment of acute uncomplicated influenza (the “flu”) in patients who have been symptomatic for no more than 2 days. Previously approved for patients 18 years and older, the FDA has now approved pediatric use as well, for patients 2 years and older. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. This approval is the first new influenza antiviral for pediatric use in over 10 years. It is important to note that studies of Rapivab evaluated primarily influenza A virus with a limited number of patients infected with influenza B virus.

FDA MedWatch: Increased Risk of Serious Liver Injury with Ocaliva

Health care providers should review dosing recommendations for Ocaliva, which can lead to injury in patients with liver impairment Read More...

On September 21, the FDA warned health care providers that Ocaliva (obeticholic acid), used for treatment of the rare, chronic liver disease primary biliary cholangitisis is being incorrectly dosed in some patients with liver impairment elevating risk for serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended. The recommended patient dosing and monitoring can be found in the manufacturer’s label. The FDA has also posted the dosing and monitoring recommendations, as well as patient information, which can be accessed here. Patients should be educated on the symptoms of potential liver injury.