Articles

On May 24, 2019, the FDA approved Piqray (alpelisib; Novartis), an oral PIK3 inhibitor, in combination with endocrine therapy with fulvestrant (Faslodex), for the treatment of postmenopausal women, as well as men, with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer and PIK3CA mutation (as detected by an FDA-approved test) that progressed during or after an ­endocrine-based treatment regimen. The FDA used its priority review designation to consider the application of alpelisib.

On May 3, 2019, the FDA approved a new indication for ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab (Herceptin)-based treatment. The FDA granted this application priority review.

On May 2, 2019, the FDA approved ivosidenib (Tibsovo; Agios) for patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years or those who have comorbidities that preclude the use of intensive induction chemotherapy. Ivosidenib was originally approved in 2018 for relapsed or refractory AML with IDH1 mutation.

On April 19, 2019, the FDA accelerated the approval of pembro­lizumab (Keytruda; Merck) plus ­axitinib (Inlyta; Pfizer) as first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda was previously approved as a single agent or in combination with other agents for many other indications and types of cancers.

On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and a susceptible FGFR3 or FGFR2 genetic alteration, as detected by an FDA-approved test, whose disease progressed after platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population.

Atlanta, GA—Treatment with gilteritinib (Xospata) significantly improved overall survival (OS) with less toxicity compared with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) and FLT3 mutation, according to the final results of ADMIRAL, a phase 3 clinical trial presented at the 2019 American Association for Cancer Research meeting.

San Diego, CA—The combination of the targeted therapy ibrutinib (Imbruvica), a protein kinase inhibitor, and the monoclonal antibody rituximab (Rituxan) extends disease-free survival by 65% and overall survival (OS) by 83% compared with standard-of-care chemotherapy with the fludarabine plus cyclophosphamide and rituximab (FCR) regimen as first-line therapy in patients with chronic lymphocytic leukemia (CLL) under age 70, according to results of the phase 3 ECOG-ACRIN 1912 trial presented at a late-breaking abstract session at ASH 2018.

San Diego, CA—Results with chimeric antigen receptor (CAR) T-cell therapy have been less robust in chronic lymphocytic leukemia (CLL) compared with B-cell acute lymphocytic leukemia and diffuse large B-cell lymphoma. Preliminary studies presented at ASH 2018 suggested that a strategy of using CAR T-cell therapy to augment the response to ibrutinib (Imbruvica) holds promise in patients with CLL.

Orlando, FL—The updated guideline on the management of metastatic ­renal-cell carcinoma (RCC) from the National Comprehensive Cancer Network (NCCN), version 3.2019, underwent a major shift in its risk categories to define preferred and alternative first-line treatments.

Orlando, FL—Germline testing should now be considered for any patient with pancreatic cancer, and molecular analysis of tumors should be considered in patients with metastatic disease, according to the updated National Comprehensive Cancer Network (NCCN) guideline for pancreatic cancer presented at the 2019 NCCN Conference.