FDA has approved Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who received prior systemic therapy. Avmapki Fakzynja Co-Pack is the first and only FDA-approved medicine for this disease.Â
Arineta, a provider of cardiovascular imaging solutions, announced that its SpotLight Duo cardiac CT scanner has received 510(k) clearance from FDA for low-dose lung cancer screening. This clearance allows providers to use a single ultra-fast CT platform for both cardiac and lung imaging and diagnostics, delivering more complete care to high-risk patients.
FDA granted accelerated approival to Emrelis (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy.Â
RyboDyn, Inc. announced on May 15 the expansion of its strategic collaboration with Moffitt Cancer Center, a global leader in cancer care and research.Â
FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1, in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.Â
FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.
The European Medicines Agency approved Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous stem cell transplant.
The European Commission granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory multiple myeloma.Â
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone, a chemotherapy regimen, in adult patients with newly diagnosed stage 2b with risk factors/3/4 Hodgkin lymphoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab for approval in the EU for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
