Articles

On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation.

On August 15, 2019, the FDA accelerated the approval of entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, for the treatment of adults and adolescents whose cancer involves neurotrophic tyrosine receptor kinase (NTRK) gene fusion that has no effective treatments. The FDA granted entrectinib a priority review and breakthrough therapy and orphan drug designations. This is the third cancer drug approved by the FDA based on a common biomarker and the second drug for patients with NTRK gene fusion.

Barcelona, Spain—Late-breaking data from 2 clinical trials presented at ESMO 2019 will likely change the treatment paradigm for pre- or postmenopausal women with hormone receptor (HR)-­positive, HER2-negative breast cancer, regardless of menopausal status. The MONALEESA-3 study and the MONARCH-2 study showed an improved overall survival (OS) with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) or abemaciclib (Verzenio) to endocrine therapy as first- or second-line therapy. The results were presented at the Presidential Session of the meeting.

San Francisco, CA—The increasing rate of infection with the human papilloma­virus (HPV) in the United States has changed the field of head and neck cancer, or oral cancer, and HPV infection now causes a growing majority (70%-90%) of oropharyngeal squamous-cell carcinomas. As its incidence is rising, so is patients’ curiosity about what sets this cancer apart from other malignancies.

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.

Leading healthcare industry expert, Dr Lee Newcomer, will deliver a keynote speech on Thursday, October 17. His talk, An Insider to Outsider’s Look at the Future of Cancer Care Delivery, begins at 8:15 am in the Lounge/Card Room, New York Athletic Club.

Virtually all patients that succumb to prostate cancer die of metastatic castration-resistant disease (CRPC). Docetaxel, the standard of care for these patients, provides a modest prolongation of survival, but there is an urgent need for novel treatment strategies.

Boston, MA—The work of 3 Harvard Medical School researchers presented at June’s AcademyHealth Conference provided a snapshot of how cancer care outcomes compare between the Veterans Health Administration (VHA) and the fee-for-service Medicare community.

Over the past decade, polarized opinion has abounded regarding robot-assisted laparoscopy. On one side, many of the surgeons who pioneered the use of the da Vinci surgical robot (Intuitive Surgical, Sunnyvale, CA) in Germany and the United States described it as “revolutionary,” heralding “a new era,” and creating a “paradigm shift.”

On July 14, 2010, the Departments of Treasury, Labor, and Health and Human Services issued interim final rules for group health plans and health insurance issuers to provide detail on how those entities are to cover the preventive services required under the Patient Protection and Affordable Care Act (PPACA).