Specialty Pharmacy

Pharmacy Times® interviewed David Silverstein, JD, MS, a partner in Axinn’s Intellectual Property and FDA practice groups, on what may be coming to market in the rapidly growing cell therapy space, and the role pharmacists may play in this emerging landscape.

The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma.

A more sensitive test capable of detecting heart function issues early in cancer treatment may be beneficial in preventing heart failure.

The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.

Pharmacy Times® interviewed J. David Robertson, PhD, director of University of Missouri Research Reactor, on a new collaboration with Advanced Accelerator Applications International to develop a targeted therapy for certain types of cancerous tumors.

The FDA has granted a fast track designation to the DNA-mediated interleukin-12 immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer.

A deep learning model was found to support the identification of imaging biomarkers on screening mammograms, according to researchers at Massachusetts General Hospital.

Two supplemental BLAs have been submitted to the FDA for enfortumab vedotin-ejfv to convert its accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer.

The FDA granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.

Data from the FIGHT trial suggests that approximately 30% of patients with non-human epidermal growth factor 2-positive GEJ cancers overexpress fibroblast growth factor receptor 2.

Pfizer's drug product is the first FDA-approved intravenous immunoglobulin with 2 maintenance dosing options for CIDP.

Building a brand is a powerful thing, whether you use it to break into an industry, follow your passions, or stand out on social media.

The FDA has approved trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

Investigators believe that an effective HIV vaccine would need to produce broadly neutralizing antibodies that would work on different strains of the virus.

Data show that 1 in 5 men and women worldwide develop cancer during their lifetime, and 1 in 8 men and 1 in 11 women die from the disease, according to the study.

A biologics license application has been submitted to the FDA for the accelerated approval of tisotumab vedotin for use in patients with recurrent or metastatic cervical cancer that has progressed on or following chemotherapy.

Libtayo is the first treatment to show a clinical benefit in patients with advanced basal cell carcinoma after hedgehog pathway inhibitor therapy in a pivotal trial.

Patients with multiple sclerosis who rely on family members as caregivers may be at particular risk for mistreatment, as those caregivers struggle to balance work, childcare, and health concerns of their own.

The findings suggest that the prevalence of these conditions among cancer survivors is nearly 40% higher than that in the general population.

Women whose tumors responded to estrogen treatment were found to benefit from hormone therapy, whereas those whose tumors did not respond experienced worsening disease.

The BTD designations for asciminib were based on the phase 3, multicenter, open-label, randomized ASCEMBL trial and a phase I trial that included patients with Ph+ CML, some of them harboring the T315I mutation.

Of 192 study participants who received Breyanzi, 73% achieved a response, including 54% who had minimal or no detectable lymphoma remaining following treatment and 19% who achieved a partial response.

The FDA has granted an accelerated approval to umbralisib for the treatment of select patients with relapsed/refractory marginal zone lymphoma and relapsed/refractory follicular lymphoma.

MET exon 14 skipping alterations occur in approximately 3% of adenocarcinomas and approximately 2% in other lung neoplasms, making them attractive potential targets for lung cancer treatment.

The collaboration begins today, which is also World Cancer Day, and the organizations will be working together to develop and share resources and educational information for the medically integrated oncology pharmacy team.

The findings suggest pre-diagnosis aspirin use might help reduce CRC mortality in the overall population by limiting metastatic spread of colorectal tumors before diagnosis.

Burnout often results from long hours, a highly regulated industry with a lot of change, and just the nature of health care in general.