FDA Updates

FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease

On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.

November 25, 2019 – Oncology News & Updates

Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer

November 18, 2019 — Oncology News & Updates

Teva Will Resume Production of Vincristine in Response to Shortage
FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma

November 11, 2019 — Oncology News & Updates

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

Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer

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.

Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer

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.

Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor

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.

Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors

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.

October 28, 2019 – Oncology News & Updates

Zejula Now Approved for Late-Line Ovarian Cancer
Trump Set to Nominate Hahn as FDA Commissioner
FDA Aims to Improve Breast Implant Guidance

Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News

The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.

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