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Monthly News Roundup - October 2017

Yescarta CAR T-Cell Therapy Approved for Lymphoma

Novel chimeric antigen receptor T cell (CAR T) therapy allows patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration (FDA) has cleared Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel), the first CAR T-cell treatment for adults with large B-cell lymphoma after failing at least two other treatments. The patient’s T-cells, a white blood cell type, is genetically modified and is reinfused to target the lymphoma cancer cells. However, serious side effects, such as cytokine release syndrome (CRS), can be serious or fatal. Visit the series to learn more about CAR-T cell therapy.

Visit the series: CAR T-Cell Therapy: A Healthcare Professional's Guide - The Top 10 Questions Answered

Shingrix Vaccine Approved for Prevention of Shingles

This month, the U.S. Food and Drug Administration (FDA) approved GSK’s Shingrix (zoster vaccine recombinant, adjuvanted), a non-live vaccine for the prevention of herpes zoster (shingles) in adults 50 years and older. Shingrix is given as two intramuscular injections, with the second dose given 2 to 6 months after the first. In studies of 38,000 people spanning a 4 year follow-up, Shingrix was effective against shingles in greater than 90% of all age groups. The CDC’s Advisory Committee on Immunization Practices now recommends Shingrix vaccine over Zoster Vaccine Live (Zostavax) and suggests those who received Zostavax should be revaccinated with Shingrix due to greater effectiveness.

FDA Approves Long-Acting Zilretta for Knee Osteoarthritis

Degenerative joint disease, also called osteoarthritis (OA), is a progressive and incurable condition and the most common form of arthritis. The U.S. Food and Drug Administration (FDA) has announced the approval of Flexion’s intra-articular corticosteroid injection Zilretta (triamcinolone acetonide) for osteoarthritis (OA) knee pain. Zilretta is a sustained-release, non-opioid formulation that provides steady concentrations of drug locally to prolong the duration of OA knee pain relief for up to 12 weeks. Effectiveness was shown in Phase 3, randomized, double-blind studies with 484 patients. Commercial availability of Zilretta is expected by November.

Janssen’s Stelara Cleared for Severe Adolescent Psoriasis

In addition to adult treatment, the interleukin antagonist Stelara (ustekinumab) from Janssen is now FDA-approved to treat moderate to severe plaque psoriasis in adolescents 12 years of age or older who are candidates for phototherapy or systemic therapy. In studies, at least two-thirds of patients receiving Stelara were responders (cleared or minimal psoriasis) at 12 weeks after receiving the first two doses at week 0 and 4. Stelara is also approved to treat adults with psoriatic arthritis or Crohn's disease. Patients who are treated with Stelara receive only four doses a year (every 12 weeks) after the first two starter doses.

FDA Approves Soliris for Generalized Myasthenia Gravis

Myasthenia gravis (MG) is a progressive immune-mediated neuromuscular disorder that leads to muscle weakness in the eyes, head, neck, trunk, limb and respiratory muscles. The U.S. Food and Drug Administration (FDA) has now approved Alexion's Soliris (eculizumab) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris selectively inhibits the terminal complement cascade, targeting a critical underlying cause of the disease. In the REGAIN studies, effectiveness was shown in those who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing.

Posted: October 2017