FDA—under the leadership of cyber-iconoclast and new director of the agency’s Center for Biologics Evaluation and Research, Vinay Prasad—is taking a new approach to COVID-19 vaccines.
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
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
Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.
Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA
Scott GottliebMark B. McClellanTwo former FDA commissioners—Scott Gottlieb and Mark B. McClellan—warned that the Trump administration’s proposal to restructure FDA by consolidating the different product centers that review drugs, biologics, animal health, tobacco, and medical devices into a single regulatory office would lead to major challenges.
FDA announced a meeting of the Oncologic Drugs Advisory Committee May 20 and 21. It will be the first ODAC meeting since President Trump was inaugurated.
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.
A novel combination therapy offers better outcomes for patients with KRAS G12C metastatic colorectal cancer that have stopped responding to chemotherapy, according to a phase III clinical trial by researchers at City of Hope.
