FDA has granted accelerated approval to Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
FDA granted Fast Track designation for IK-930, a novel TEAD inhibitor targeting the Hippo signaling pathway, in patients with unresectable NF2-deficient malignant pleural mesothelioma.
FDA announced it will issue marketing denial orders to all JUUL e-cigarette products. The products must be removed from shelves across the country or risk enforcement action, as FDA has ruled they do not meet the public health standard required to be authorized for sale.
FDA granted Orphan Drug Designation to stage LSD1 inhibitor iadademstat for the treatment of patients with small cell lung cancer.
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.
