Ribonexus (previously Aglaia Therapeutics) and French pharmaceutical group Pierre Fabre signed an exclusive license agreement on a series of Pierre Fabre-patented small molecules targeting the eukaryotic translation initiation factor 4A (eIF4A). This target is highly expressed in a variety of solid and hematologic cancers, including melanoma, and associated with resistance to many current therapies.
FDA granted accelerated approval to Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, who were previously treated with two or more tyrosine kinase inhibitors. FDA also approved Scemblix for adult patients with Ph+ CML in CP with the T315I mutation.
The Oncology Center of Excellence and the Center for Drug Evaluation and Research have developed a publicly available database with information about accelerated approvals in oncology and hematologic malignancies.
FDA and the the European Medicines Agency accepted the Supplemental Biologics License Application and Type II Variation, respectively, for Kymriah (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma after two prior lines of treatment. FDA also granted priority review to the sBLA for Kymriah in adult patients with r/r FL.
A skin cancer vaccination called IFx-Hu2.0 received FDA “fast track” designation to treat patients with advanced cutaneous melanoma who have not responded to other therapies and medication.
FDA took several actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
Foundation Medicine signed agreements for in-network provider status with Humana Military and Health Net Federal Services, which administer the TRICARE health program for military members, retirees, and their families.
Citius Pharmaceuticals entered into an agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, to acquire its exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma.
Cardinal Health was awarded a $750,000 contract by FDA to implement an 18-month real world evidence study as part of the agency’s efforts to advance the applicability of RWE in regulatory decision-making.
The European Commission approved Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 (CPS ≥10) and who have not received prior chemotherapy for metastatic disease.
