Clairity Inc. received FDA De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025—propelling a new era of precision medicine in breast cancer.
The European Commission June 3 approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone—a chemotherapy regimen—in adult patients with newly diagnosed stage 2b with risk factors, stage 3, and stage 4 Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on April 25.
The National Medical Products Administration in China approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
Meitheal Pharmaceuticals Inc. on May 29 announced it has launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd., paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane, in the U.S.
FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.
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.
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.
RyboDyn, Inc. announced on May 15 the expansion of its strategic collaboration with Moffitt Cancer Center, a global leader in cancer care and research.
