2- Tuesday Pharmacy Practice News – 21th December

1 – Acalabrutinib Shows Significant Survival Benefit in Patients With Chronic Lymphocytic Leukemia 

• The efficacy of acalabrutinib monotherapy was maintained and showed a significant progression-free survival (PFS) benefit over standard-of-care regimens in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) after 3 years of follow-up
• Acalabrutinib is a Bruton tyrosine kinase inhibitor (BTKi) intended for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
• It is also currently indicated for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL), according to an AstraZeneca press release.
• The multicenter phase 3 study randomized patients with R/R CLL 1:1 to receive acalabrutinib 100 mg orally twice daily or investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab until disease progression or unacceptable toxicity.
• Out of 310 enrolled patients, acalabrutinib significantly sustained the investigator-assessed PFS versus idelalisib/bendamustine plus rituximab combinations at a median follow-up of 36 months.
• Additionally, the PFS benefit was consistently shown in high-risk subgroups.

Source: Pharmacy Times

2 – Experts Review Cabotegravir, Rilpivirine Therapy for Treatment of HIV Infections

• During a presentation at the American Society of Health-System Pharmacists 2021 Midyear conference, the panelists reviewed long-acting (LA) antiretroviral therapies for the prevention and treatment of HIV infections, specifically a cabotegravir LA with rilpivirine LA intramuscular treatment.
• Cabotegravir LA with rilpivirine LA is for the treatment of HIV-1 infections that is intended to replace antiretroviral regimens for those who are virologically suppressed on those regimens.
• The individuals must have no history of unsuccessful treatment and no known or suspected resistance to either cabotegravir or rilpivirine.

Source: Pharmacy Times

3 – FDA Expands EUA for Pfizer COVID-19 Booster to Include 16- and 17-Year-Olds

• The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include the use of a single booster dose for individuals aged 16 and 17 years, at least 6 months after the completion of primary vaccinations with the Pfizer vaccine.
• The new action makes the FDA-authorized Pfizer vaccine and the FDA-approved Comirnaty vaccine, both of which are mRNA vaccines, the only vaccines that are available for 16- and 17-year-olds.
• This age group should only receive the Comirnaty or Pfizer booster doses, according to the FDA.
• New evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group.
• A single booster dose of the vaccine for those vaccinated at least 6 months prior will help provide continued protection against COVID-19 in this and older age groups

Source: Pharmacy Times

4- FDA Issues Emergency Use Authorization for Long-Acting Antibody Combination, First Pre-Exposure Prophylaxis for COVID-19

• Officials with the FDA have approved an emergency use authorization (EUA) for tixagevimab co-packaged with cilgavimab as the first antibody therapy for pre-exposure prophylaxis of COVID-19. First doses will be available soon, according to a press release.
• The EUA was granted for adults and adolescents 12 years of age and older who 40 kg weigh or more who are moderately to severely immunocompromised due to a medical condition or immunosuppressive medications, and who therefore may not mount an adequate immune response to vaccination.
• It is also approved in those for whom COVID-19 vaccination is not recommended. Recipients of the long-acting antibody combination should not be currently infected with COVID-19 or had recent known exposure to a person infected with SARS-CoV-2.

Source: Pharmacy Times

5 – FDA Approves Lyvispah for Treatment of Spasticity Resulting From MS

• The FDA has approved baclofen oral granules for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
• This drug may also help patients with spinal cord injuries and other spinal cord diseases.
• Nearly 1 million people in the United States live with MS, and the prevalence of spasticity within this patient population has been estimated to be as high as 67%, according to a company statement.
• Additionally, the prevalence of dysphagia in individuals with MS has been reported to be between 34% and 43%, with aspiration pneumonia frequently cited as a contributing factor in deaths of these patients.
• The most common adverse reactions in patients treated with baclofen for spasticity are confusion, constipation, dizziness, drowsiness, fatigue, headache, hypotension, insomnia, nausea, urinary frequency, and weakness.

Source: Pharmacy Times

6 – Pfizer, BioNTech Say 3 Doses of COVID-19 Vaccine ‘Neutralize’ Omicron Variant

• New data from Pfizer and BioNTech demonstrate that 3 doses of the COVID-19 vaccine successfully neutralize the Omicron variant, whereas 2 doses show significantly reduced neutralization titers, according to a press release.
• The companies noted that these findings are from an initial laboratory study.
• Sera obtained from individuals who have been vaccinated 1 month after receiving the booster dose neutralized the Omicron variant to levels comparable to those observed for the wild-type SARS-CoV-2 spike protein after 2 doses.
• Although 2 doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine

Source: Pharmacy Times

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