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: […]

Although breast cancer most commonly occurs in women, approximately 2500 men are diagnosed with breast cancer each year in the United States alone. Unfortunately, men have historically been excluded from clinical trials for breast cancer treatments, resulting in limited data on treatment safety and efficacy in men. Despite limited data, breast cancer in men is […]

The dawn of the cancer immunotherapy era has brought with it renewed hope in the treatment of patients with advanced tumors. While the immune checkpoint inhibitors have offered strong and durable cancer control to some patients, the reality is that not all patients benefit from these treatments. Many studies have included assessment of potential biomarkers […]

Promoting the use of patient-focused outcome measurement in drug development has been a major focus of the United States Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). To continue fostering this goal, the CDER recently published an update of their Clinical Outcome Assessment (COA) Compendium. This compilation was designed to act […]

In breast, ovarian, and pancreatic cancer, deficiencies in genes related to homologous recombination repair (HRR), including BRCA1/2 and ATM, are known to be associated with increased sensitivity to poly(ADP-ribose) polymerase (PARP) inhibitors. According to preliminary results from the ongoing phase III PROfound trial, prostate cancer can now be added to this list. In a recent […]

We have all heard the warnings that the rate of avoidable medical errors is staggeringly high, with estimations of hundreds of thousands of preventable deaths annually in the US. Deaths from medical error has even been referred to by some as an epidemic. These reports have become viral in their reach by infiltrating the lay […]

Small cell lung cancer (SCLC) is a devastating diagnosis, and new therapeutic options are desperately needed in this setting. Previously, first-line treatment of extensive-stage SCLC was limited to combination chemotherapy, which is associated with modest overall survival (OS), but inroads have been made with the application of immune checkpoint inhibitor antibodies to this setting. Immunotherapy […]

On June 18, 2019, the United States Food and Drug Administration granted accelerated approval to the PD-1 inhibitor pembrolizumab for use as a monotherapy in the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other line of therapy. This approval was […]