The FDA is working in close collaboration with global regulatory partners to evaluate the controls in place and publish guidance on preventing unacceptable levels of nitrosamine in drugs.
Biosimilars Mvasi and Kanjinti are now available in the United States.
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
More marked increases in incidence observed from 2006 to 2013 than from 1973 to 2006.
Increased odds ratios for cancer observed in different categories of OSA for women, not men.
The FDA has approved Venclexta in combination with Gazyva for the treatment of patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA approval was supported by data from the phase 3 KATHERINE study.
A study presented at the Academy of Managed Care Pharmacy Managed Care and Specialty Pharmacy 2019 Annual Meeting showed that an oral oncology split-fill program implemented by AllianceRx Walgreens Prime resulted in improved adherence and reduced pharmacy costs and medication waste.
New joint guideline from ASTRO, ASCO, and AUA offers an alternative to conventional radiation regimens for those patients who opt for treatment instead of active surveillance or surgery.
