All Articles
On August 31, 2021, proposed revisions to the United States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding – Sterile Compounding (USP) were published. For several years, different versions of USP have fostered concern and confusion about whether these pharmacy standards apply to (and will impact) the drug preparation and handling that is an integral part of oncology medical practices, as well as other specialties. Read More ›
By William King
The use of the PARP inhibitor olaparib (Lynparza) for 1 year after receiving standard chemotherapy in the neoadjuvant or the adjuvant setting significantly improved invasive disease-free survival in patients with high-risk, early-stage, HER2 negative breast cancer and BRCA1 or BRCA2 mutations, according to results presented at the American Society of Clinical Oncology 2021 virtual annual meeting. Read More ›
The novel BCL-2 inhibitor, lisaftoclax (APG-2575), elicited encouraging responses and acceptable tolerability in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and other hematologic malignancies, according to results of a phase 1 study presented at the American Society of Clinical Oncology 2021 virtual annual meeting. Read More ›
On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma) Read More ›
By William King
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 ›