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Monthly News Roundup - May 2017

Actemra: First Drug Approved to Treat Giant Cell Arteritis

Actemra (tocilizumab) from Hoffman La Roche has gained a new indication as the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is a group of disorders that leads to swelling of blood vessels. In a clinical study of 251 patients with giant cell arteritis, the primary endpoint, defined as the proportion of patients achieving sustained remission from Weeks 12 to 52, was met. Sustained remission included absence of symptoms, normalization of inflammatory laboratory tests, and tapered use of prednisone. More patients receiving Actemra plus prednisone achieved sustained remission compared to patients receiving placebo plus prednisone.

A First: FDA OK’s Keytruda For Any Solid Tumor Based on Biomarker

For the first time in cancer treatment, a drug has been FDA-approved based on a tumor’s biomarker (specific genetic marker) without regard to the tumor’s original location, such as with breast cancer. Merck’s Keytruda (pembrolizumab) can now be used for the treatment of patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This use includes patients who have failed therapy with no alternatives and those with advanced colorectal cancer who failed certain chemotherapy drugs. In studies, a total of 15 cancer types were identified, most commonly colorectal, endometrial and other gastrointestinal cancers.

IL-6 Antagonist Kevzara Cleared to Treat Rheumatoid Arthritis (RA)

Kevzara (sarilumab), from Regeneron and Sanofi, is an interleukin-6 receptor (IL-6R) antagonist newly FDA-approved for the treatment of patients with moderate-to-severe rheumatoid arthritis who have had an inadequate response or cannot tolerate one or more disease-modifying antirheumatic drugs (DMARDs). Kevzara may be used alone or in combination with methotrexate (MTX) or other conventional DMARDs. In the MOBILITY study, treatment with Kevzara plus MTX improved physical function and demonstrated significantly less radiographic progression of structural damage compared to placebo plus MTX. In studies, common side effects included neutropenia, increased liver enzymes, and injection site redness, among others.

FDA Approves Radicava to Treat Amyotrophic Lateral Sclerosis

It's been over 2 decades since a new drug was approved for ALS. This month, the FDA approved Radicava (edaravone) for amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. ALS is a rare disease that kills the nerve cells that control voluntary muscles, and most people die from respiratory failure. Radicava is a free radical scavenger that relieves oxidative stress and may affect progression of ALS. In studies at week 24, individuals receiving Radicava declined less in assessment of daily functioning compared to placebo. Common side effects reported in clinical trials were bruising and gait disturbance.

AstraZeneca’s Imfinzi Cleared for Advanced Bladder Cancer

Imfinzi (durvalumab) has been FDA-approved for the treatment of patients with advanced urothelial carcinoma who have disease progression despite use of platinum-containing chemotherapy with or without surgery. Imfinzi is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody. In studies, Imfinzi had an objective response rate (ORR) of 17%, regardless of PD-L1 status, with an ORR of 26.3% in patients with PD-L1 high-expressing tumors. Among 31 patients who responded to treatment, 14 patients (45%) had ongoing responses of at least 6 months and 5 patients (16%) at least 12 months. Of all evaluable patients, 2.7% achieved a complete response.

Posted: May 2017