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.
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.
The National Comprehensive Cancer Network added Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, to the NCCN Clinical Practice Guidelines in Oncology. Lymphir is included based on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that the drug is appropriate as an option for patients with CTCL.
