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.
The European Commission approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score ≥ 5.
Point32Health and Takeda Pharmaceuticals America, Inc. signed a risk-sharing agreement around Takeda’s Alunbrig (brigatinib), a potent and selective tyrosine kinase inhibitor that is approved for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
