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  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens

On October 23, 2019, the FDA approved the PARP inhibitor niraparib (Zejula; Tesaro) for the treatment of patients with homologous recombination deficiency (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer, after ≥3 chemotherapy regimens. HRD is defined by a deleterious or suspected deleterious BRCA mutation, or a genomic instability associated with disease progression >6 months after the tumor’s response to the last platinum-based chemotherapy. On the same day, the FDA also approved the Myriad myChoice CDx test to select patients for niraparib therapy based on the HRD tumor status.

Anaheim, CA—The speed at which the genetics revolution has propelled forward in oncology has created enormous ramifications and unanticipated challenges, according to Suzanne Mahon, RN, DNSc, AOCN, AGN-BC, CNS, Professor, Division of Hematology/Oncology, Department of Internal Medicine, Saint Louis University, MO.

Chicago, IL—Tumor-specific antigens provide personalized targets for immunotherapy. Neoantigen vaccines are a new type of immunotherapy that can elicit immune response and achieve remission. Evidence is compelling to support neoantigens as the target of effective immune responses against cancer and to support an association between neoantigen load with improved clinical outcome, said Patrick Alexander Ott, MD, PhD, Clinical Director, Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA, at ASCO 2019.

  • Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
  • Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda in Advanced Head and Neck Cancers
  • Discussing Costs of Genomic Testing with Patients
San Diego, CA—Great progress has been made in the fight against cancer, but not all patients have benefited equally. Disparities exist among specific populations in terms of survival and cancer-related mortality, incidence and prevalence, as well as adverse health conditions, according to Karen M. Winkfield, MD, PhD, Director, Office of Cancer Health Equity, Wake Forest Baptist Medical Center Comprehensive Cancer Center, Winston-Salem, NC. Dr Winkfield discussed the topic at the 2019 ASCO Quality Care Symposium.
San Diego, CA—Patient-centered clinical pathways may hold the promise of truly personalized medicine, improving value-based care and clinical outcomes. However, according to Cary P. Gross, MD, Director, Cancer Outcomes, Public Policy and Effectiveness Research Center, Yale School of Medicine, New Haven, CT, substantial challenges still stand in the way of including the patient’s voice in these pathways.
San Diego, CA—The economic burden faced by patients with cancer who have low income may be more pervasive than previously thought. According to data presented at the 2019 ASCO Quality Care Symposium, even patients enrolled in clinical trials are at high risk for financial toxicity.
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review.
On August 2, 2019, the FDA approved pexidartinib (Turalio; Daiichi Sankyo) capsules, a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor (TGCT), which is associated with severe morbidity or functional limitations, who are not candidates for surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT. The FDA granted pexidartinib a priority review and breakthrough therapy and orphan drug designations.
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