In late August, the US Food and Drug Administration (FDA) granted priority review to the Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received one or more prior lines of therapy. Zanubrutinib had previously been given a Breakthrough Therapy designation for this indication. MCL is […]

On August 21, an application for the androgen receptor inhibitor enzalutamide was granted priority review by the United States Food and Drug Administration (FDA). Enzalutamide is currently approved for treatment of both nonmetastatic and metastatic castration-resistant prostate cancer (mCRPC). This new application adds an indication for enzalutamide as a treatment for patients with metastatic hormone-sensitive […]

Pneumonitis is emerging as an adverse event of many oncology targeted therapies, including immune checkpoint inhibitors and some tyrosine kinase inhibitors. On September 13, the US Food and Drug Administration (FDA) released an important safety communication regarding the risk of lung inflammation, including pneumonitis and interstitial lung disease, associated with another class of targeted therapies: […]

Pharmaceutical companies often put a tremendous amount of effort into connecting with prominent oncologists. These key stakeholders can indeed offer a wealth of information. Oncologists, in particular, can provide pharmaceutical companies with valuable insights into what factors guide their treatment decisions. However, many clinicians are now withdrawing from these discussions. Heavy caseloads and tight schedules […]