FDA Grants Priority Review to Keytruda Plus Padcev for Urothelial Carcinoma
December 1st 2023The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
FDA Fast Tracks eFFECTOR Therapeutics' Zotatifin Combo for ER+/HER2– Breast Cancer
December 1st 2023FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with endocrine therapy and a CDK4/6 inhibitor.
FDA Accepts Arcutis Biotherapeutics' sNDA for Roflumilast Cream for Atopic Dermatitis
November 30th 2023Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.
FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy
November 29th 2023The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
Follicular Lymphoma Drug Co-Developed by AbbVie and Genmab Gets FDA Breakthrough Designation
November 27th 2023AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.
FDA Approves Keytruda Plus Chemotherapy for Gastric, Gastroesophageal Junction Adenocarcinoma
November 17th 2023Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric/GEJ adenocarcinoma.
FDA Approves Truqap Plus Faslodex for Advanced HR-Positive Breast Cancer
November 17th 2023Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.