FDA announced the launch of the “Next Legends” Youth E-cigarette Prevention Campaign, which aims to protect youth from the dangers of tobacco use. The campaign will educate American Indian/Alaska Native youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging.
Reena Philip was named associate director of biomarkers and precision oncology at FDA’s Oncology Center of Excellence.
FDA approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as first-line treatments for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, regardless of PD-L1 status.
FDA granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved for priority review the Biologics License Application for Omblastys (omburtamab) in the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
FDA granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
In a letter addressed to FDA Commissioner Robert Califf, Republican leaders of the House Committee on Energy and Commerce and two of its subcommittees raised questions about the increasing number of clinical trials conducted in China by companies seeking FDA approval for “me-too” checkpoint inhibitor drugs.
FDA granted marketing authorization to the Parsortix System for the harvesting of circulating cancer tumor cells in metastatic breast cancer.
FDA approved a combination of Tibsovo (ivosidenib) and Vidaza (azacitidine) for the treatment of patients with newly diagnosed IDH1-mutant acute myeloid leukemia who are 75 years or older or with comorbidities that prevent the use of induction chemotherapy.
An analysis conducted by Friends of Cancer Research showed that the FDA Breakthrough Therapy Designation criteria select drugs that lead to better outcomes for patients with lung cancer.