Specialty Pharmacy

Baricitinib (Olumiant; Eli Lilly and Company) is the first systemic treatment to be approved by the FDA for severe alopecia areata, which affects an estimated 300,000 patients in the United States.

These results from 3 separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with ustekinumab (Stelara) were presented at Digestive Disease Week meeting in San Diego, California.

In an analysis of data from 2 patient cohorts included in the phase 2 BYLieve study, investigators found that the data may indicate an increased dependence on the mutant PI3K-α.

JZP458, a recombinant Erwinia-derived ASNase from a Pseudomonas fluorescens expression platform, was previously approved by the FDA for patients with ALL/LBL who had developed hypersensitivity to Escherichia coli (E. coli)–derived ASNase.

Investigators reported that individuals who completed 10 cycles of lurbinectedin and doxorubicin who then switched to lurbinectedin as a monotherapy tended to have maintained or improved tumor response.

Investigators found that individuals receiving selinexor had a median PFS of 5.7 months compared to 3.8 months for those given the placebo, with a stratification adjusted hazard ratio of 0.70.

Additionally, the 2-time dependent variables, dose reduction, and relative dose intensity 2 (RDI2) were included in the respective model as covariates to explore the connection to overall survival.

Approval in this patient population makes dupilumab the first and only biologic medicine approved for the treatment of moderate-to-severe atopic dermatitis from infancy through adulthood.

Overall, the investigators observed that the CR, undetectable minimal residual disease rates, progression free survival, and overall survival amomg the patients enrolled in the trial were favorable.

In a collaboration using a neutral zone, organizations do not have access to each other’s data, but will instead have access to insights gathered by pooling their data together with other organizations for analysis by artificial intelligence technology.

Self-audits help onsite frontline pharmacy leaders and team members to assess compliance before an external surveyor enters their pharmacy to inspect medication use processes.

Further analyses showed guselkumab provided patients with sustained improvements in measures of health-related quality of life, fatigue, pain, and work productivity.

In addition to the new approval for rheumatoid arthritis, Riabni has already been approved for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

Beth Koselke, PharmD, BCOP, discusses the impact of pharmacist intervention in clinical trial enrollment, specifically in the MYLUNG Consortium.

All individuals who received second-line chemotherapy regimens met the PFS2 endpoint and all but 1 individual had died at time of data cutoff, according to a presentation at 2022 ASCO Annual Meeting.

Rucaparib at the 400 mg dosage combined with nivolumab and ipilimumab for 4 cycles will continue onto a phase 2 trial for individuals with relapsed ovarian cancer.

Biomarker positive patients were randomized to maintenance rucaparib 600 mg or matched placebo within 10 weeks of completing PBC until disease progression.

Analysis included a 29% objective response rate in cohort 4 of the C-144-01 study, the company says.

Findings of the phase 2 cohort and the phase 1b cohort of the KRYSTAL-1 study are being presented at the 2022 American Society of Clinical Oncology Annual Meeting.

Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeding with a once-weekly prophylactic dosing.

The researchers noted that the objective of the study was to assess the trends of 1L PARPi maintenance treatment uptake and PFS of patients with newly diagnosed AOC.

Trastuzumab deruxtecan shows superior and clinically meaningful progression-free survival and overall survival benefit in patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor-positive or negative disease.

Sacituzumab govitecan-hziy (Trodelvy) found to lower the risk of disease progression or death by 34% in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.

With a median follow-up of 90 months, individuals receiving palbociclib in combination with letrozole had numerically longer OS compared to placebo, but it was not deemed statistically significant.

Overall outcomes were consistent with axicabtagene ciloleucel in the real-world setting, regardless of race or ethnicity, in adults with relapsed or refractory large B-cell lymphoma.

Brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine shows improved overall survival compared with standard chemotherapy in patients with previously untreated, advanced stage classical Hodgkin lymphoma.

An immune checkpoint inhibitor plus ramucirumab found to improve overall survival versus standard of care in patients with advanced non-small cell lung cancer.

Ibrutinib plus bendamustine-rituximab and rituximab maintenance was found to lower the risk of disease progression or death by 25% compared with placebo in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Uliledlimab plus toripalimab (Tuoyi) shows significant response rates in patients with advanced non–small cell lung cancer previously ineligible to receive standard-of-care treatment.

Analysis shows that different genetic mutation profiles in tumors harboring PIK3CA mutation did not affect the treatment benefit with alpelisib (Piqray) combined with fulvestrant in individuals with HR+/HER2- advanced or metastatic breast cancer.