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FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of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.
Japan’s Ministry of Health, Labour, and Welfare has accepted for review a new drug application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone or pomalidomide plus dexamethasone as a treatment for relapsed or refractory multiple myeloma.
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.
Astera Cancer Care, a partner of the One Oncology Network, has partnered with Knowtex to develop advanced voice and generative AI workflows tailored specifically for oncology.
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.