FDA issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
A meta-analysis of 25 studies—totaling over 5,000 participants—focused on a question that has been troubling patients, physicians, and regulators: Does treatment with CAR T-cell therapy contribute to the development of secondary cancers?
FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous injection.
FDA has granted orphan drug designation for the GSK-3β inhibitor elraglusib, for treatment of soft tissue sarcoma.
FDA is seeking consumer representatives to serve on the Oncologic Drugs Advisory Committee.
FDA approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
FDA approved durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
FDA accepted Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma.
FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
