The FDA has approved the second herpes zoster vaccine for adults ≥ 50 years of age. The new vaccine is delivered in two intramuscular doses, with the second dose between two and six months following the first. The vaccine is a non-live, recombinant subunit vaccine that has shown 90% efficacy across all age groups in the prevention of shingles. Approval was based on safety and efficacy trials of more than 38,000 adults, which showed 90% efficacy over a four-year follow-up. The vaccine also reduced the overall incidence of postherpetic neuralgia. The new vaccine is marketed as Shingrix. On Oct. 25, the CDC’s Advisory Committee on Immunization Practices voted to recommend the new vaccine for those ≥ 50 years of age. The other shingles vaccine, Zostavax, is recommended only for those > 60 years of age. However, the committee, on a close vote, agreed to recommend Shingrix over Zostavax for all age groups. The committee also recommended Shingrix for patients who have received Zostavax already — as long as there was a minimum of eight weeks between vaccines.
The FDA has approved the second gene therapy for cancer, this time for the treatment of adults with certain types of large B-cell lymphoma who have failed or relapsed after at least two other types of therapy. Axicabtagene ciloleucel is a chimeric antigen receptor T-cell therapy in which the patient’s T cells are extracted and genetically modified to include a new gene that targets and kills the lymphoma cells once reinfused into the patient. Safety and efficacy were shown in a trial of more than 100 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate with the new treatment was 51%. The drug also is approved for the treatment of primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma arising from follicular lymphoma. Axicabtagene ciloleucel is marketed as Yescarta, with an announced price of $373,000 per patient.
To curb health fraud, the FDA is issuing warning letters to four companies marketing cannabidiol (CBD, a component of marijuana) who claim their product treats or cures serious diseases, especially cancer. CBD is not FDA approved in any drug product for any indication. It is marketed as oil drops, capsules, syrups, teas, topical lotions, and creams. Along with claims that CBD prevents, reverses, and cures cancer, there also are claims that the drug treats Alzheimer’s disease and other chronic conditions. Recipients of the warning letters were Greenroads Health, Natural Alchemist, That’s Natural! Marketing & Consulting, and Stanley Brothers Social Enterprises, LLC, makers of more than 25 products that claim to “combat tumor and cancer cells,” “make cancer cells commit suicide without killing other cells,” prevent cancer cells from growing, and treating breast cancer. CBD is promoted as a “non-psychoactive cannabinoid.”