September 2021, Vol 11, No 9

On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma) Read More ›

Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States.1 Over the past 2 decades, cases of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC) have been increasing at an alarming rate among men in the United States.2,3 According to the American Cancer Society, approximately 54,000 cases of oropharyngeal and oral cavity cancer will be diagnosed in the United States in 2021, and more than 10,000 individuals will die from the disease.4 OPSCC is often diagnosed at an advanced stage, resulting in increased mortality and morbidity. Read More ›

On June 16, 2021, the FDA approved a new indication for avapritinib (Ayvakit; Blueprint Medicines) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast-cell leukemia. The FDA granted this indication a priority review and breakthrough therapy and orphan drug designations. Read More ›

On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received ≥1 previous lines of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor. Daratumumab and hyaluronidase, as well as pomalidomide, are each already approved for the treatment of patients with multiple myeloma, alone or in combination with other drugs. Read More ›

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. Read More ›

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication. Read More ›

On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication. Read More ›

There does not exist a cookie-cutter approach to treating patients with cancer, due to a multitude of patient-related factors, such as gender, race, age, biomarkers, and comorbidities. Despite these factors, which may affect how individuals respond to specific therapeutic protocols, there are general guidelines, including those published by the National Comprehensive Cancer Network (NCCN),1 which can be used to help guide treatment practices to promote optimal clinical outcomes. Read More ›

The majority of leadership opportunities currently available in the medical practice community require individuals to be responsible for the operations of previously established businesses and teams. As a result, new and seasoned leaders alike are often finding themselves facing unique challenges as they navigate the nuances of assuming leadership of existing practices. This transition can be equally challenging for the staff members. In this article, we offer some strategies you can use to facilitate the process. Read More ›

According to results from a recent study, balstilimab, an investigational PD-1 inhibitor, demonstrated meaningful and durable clinical activity in patients with recurrent or metastatic cervical cancer. These findings were presented by Cailin E. Joyce, MD, Director, Applied Technology, Agenus, Boston, MA, during the American Society of Clinical Oncology 2021 virtual annual meeting. Read More ›