New Options for Angina, Metastatic Breast Cancer, HCV

Coronary-Sinus Reducer System – Refractory Angina

Researchers have developed a coronary-sinus reducing device to improve symptoms and quality of life for patients suffering from refractory angina.¹

The device is balloon expandable, made of stainless steel, and shaped like an hourglass, which increases pressure in the coronary sinus and focal narrowing to redistribute blood into ischemic myocardium.

To test the device’s efficacy, researchers assigned 104 patients who scored a class III or IV angina on the Canadian Cardiovascular Society (CCS)’s scale. The patients were divided into a treatment group (those implanted with the device) or a control group who received a sham procedure. At 6 months, researchers found that 35% of the patients in the treatment group (18 of 52 participants) had an improvement in at least 2 CCS angina classes compared to 15% of those in the control group (8 out of 52 patients).

The investigators noted no significant difference in exercise time improvement. After the 6-month period, 1 patient from the treatment group experienced a myocardial infarction and in the control group 1 patient died while 3 others had a heart.
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Labrance – Postmenopausal Women With Advanced Breast Cancer

The FDA has announced accelerated approval for the use of lbrance (palbociclib) to treat patients with metastatic breast cancer.²

Lbrance works by thwarting cyclin-dependent kinases molecules 4 and 6 from promoting cancer cell proliferation.

The drug is being approved 2 months in advanced to the original prescription drug user fee goal date (April 13, 2015) under the FDA’s accelerated approval program based on clinical data of the drug’s efficacy for life-threatening disease treatment.

In a clinical study, 165 postmenopausal women with ER-positive, HER2-negative advanced breast cancer patients were assigned to receive lbrance in tandem with letrozole or letrozole by itself. Compared to those only receiving letrozole, patients who received lbrance in combination to letrozole lived longer without their disease progressing (10.2 months vs. 20.2 months).

The most common side effects include low levels of white blood cells (leukopenia), neutropenia (decreased infection-fighting white blood cells), anemia, nausea, hair loss, inflammation of the mouth lining, upper respiratory infection, diarrhea, decreased appetite, vomiting, peripheral neuropathy, nosebleed, and a lack of energy and strength.

Grazoprevir/Ebasvir Combo – HCV

The FDA made plans to revoke the breakthrough therapy status of grazoprevir and elbasvir combination therapy used to treat chronic hepatitis C virus (HCV) infection, according to 2014 financial results from a recent report released by Merck.³

Note: The FDA grants breakthrough therapy status to drugs that have shown substantial improvement in at least 1 clinical endpoint over all other available treatments.

“Consistent with established FDA policies and procedures that govern the breakthrough therapy designation program, the FDA has indicated its determination is based on the availability of newly registered drugs that address this medical need. The company expects to discuss this matter with the FDA and does not expect that it will impact its ability to file [a new drug application] for this combination regimen or the timing of that filing,” said Sarra S. Herzog, the spokesperson for Merck.

According to Herzog, Merck received a breakthrough therapy designation for grazoprevir/elbasvir in October 2013.  The drug combination’s treatment regimen was identified as safe and well tolerated among patients with HCV genotype 1 and cirrhosis who were treated with ribavirin and peglyated interferon (after 12 or 18 weeks) at the 2014 Liver Meeting in Boston.

Moving forward, Merck still purposes to file a new drug application for the treatment regiment with the FDA in the months ahead.

—Michelle Canales

References:

1. Verheye S, Jolicoeur EM, Behan MW, et al. Efficacy of a device to narrow the coronary sinus in refractory angina. NEJM. 2015 January [epub ahead of print] doi: 10.1056/NEJMoa1402556.

2. FDA. FDA approves lbrance for postmenopausal women with advanced breast cancer [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432871.htm. Accessed February 5, 2015.

3. Healio. FDA to retract breakthrough therapy designation of grazoprevir/elbasvir combo for HCV [press release]. www.healio.com/hepatology/hepatitis-c/news/online/%7B80ecfa59-9220-44c7-908d-7319c768a15b%7D/fda-to-retract-breakthrough-therapy-designation-of-grazoprevirelbasvir-combo-for-hcv?sc_trk=internalsearch. Accessed February 5, 2015.