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Two years of abiraterone acetate (Zytiga) plus prednisone added to androgen-deprivation therapy (ADT) improved metastasis-free survival and overall survival compared with ADT alone in men with nonmetastatic castration-sensitive prostate cancer, whereas the addition of enzalutamide (Xtandi) to ADT had no benefit, and much greater toxicity. Read More ›
Cholangiocarcinoma (CCA) involves genetic heterogeneity, highlighting the need to identify new inherited variants, as discussed at the 3rd Annual CCA Summit in Session II, “Molecular Epidemiology of CCA.” Read More ›
On December 15, 2021, the FDA approved a new indication for abatacept (Orencia; Bristol Myers Squibb), a selective T-cell co-stimulation modulator, in combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft-versus-host disease (GVHD) in adults and pediatric patients aged ≥2 years receiving hematopoietic stem-cell transplantation from a matched or 1 allele-mismatched unrelated donor. The FDA granted abatacept a priority review and breakthrough therapy and orphan drug designations. Read More ›
On December 3, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for the adjuvant treatment of adult and pediatric patients (age ≥12 years) with stage IIB or IIC melanoma following complete resection. Read More ›
On November 30, 2021, the FDA approved the combination of subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech) plus carfilzomib (Kyprolis; Amgen) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1 to 3 previous lines of therapy. Read More ›
On November 29, 2021, the FDA accelerated the approval of pafolacianine (Cytalux; On Target Laboratories), a novel fluorescent imaging agent, for adults with ovarian cancer as an adjunct for identifying inoperable malignant lesions. Read More ›
The results of a randomized, double-blind phase 3 study established the equivalence of bevacizumab reference to its biosimilar MIL60 in terms of clinical efficacy, safety, population pharmacokinetics, and immunogenicity in patients with nonsquamous NSCLC. Read More ›
The results of a noninterventional, retrospective study showed that rituximab originator and the rituximab-abbs biosimilars yielded comparable efficacy and tolerability in the first-line treatment of patients with CLL and NHL, with rituximab-abbs use resulting in cost-savings. Read More ›
Findings from modeling studies support adjuvant continuation of pertuzumab plus trastuzumab for patients achieving pathologic complete response among patients with high-risk, HER2-positive early breast cancer. Read More ›
Real-world outcomes from a retrospective, single-center study suggested that pegfilgrastim or its biosimilar pegfilgrastim-cbqv does not increase febrile neutropenia or delayed engraftment risk in patients with lymphoma and CLL and may be safe to use after administration of chemotherapy. Read More ›