Cullinan Oncology announced that the FDA has granted Breakthrough Therapy Designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring epidermal growth factor (“EGFR”) exon ...
The FDA granted priority review to the lung cancer indication based on results of the randomized phase 3 CheckMate -9LA trial, which assessed the combination as first-line treatment for patients with metastatic NSCLC regardless of PD-L1 expression or histology. Res...
“We are thrilled to receive the FDA’sFast Trackdesignation for IVS-3001,” said Dr. Jake Kushner, CEO of Invectys. “This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with soli...
The legalization of recreational marijuana in Minnesota has created daily conversations about how to incorporate the use of cannabis into treatment plans for patients with cancer, explained Marie Parish, PharmD, BCOP, of Mayo Clinic. September 15th 2024 Advances in the Treatment of Resectable NSCLC: ...
The ODD demonstrates the need for new treatment options of patients living with ADPDK as well as the potential AP303 has in treating this population.1 "We are very excited that AP303 has been granted ODD by the FDA,” said Gavin Xia, co-founder, chairman, and CEO...
The FDA has granted a priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non–small cell lung cancer who express PD-L1 and have progressed after a platinum-containing regimen. Sandra Horning, MD ...
US FoodDrug Administration (FDA)
The FDA has accepted an investigational new drug (IND) application for FK-PC101, a personalized prostate cancer immunotherapy for the treatment of patients with a high risk of recurrence following radical prostatectomy, announced Theragent in a news release.1 ...
The highly selective ALK inhibitor AP26113 has been granted a Breakthrough Therapy Designation by the FDA for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who received prior treatment with crizotinib (Xalkori). The designation was based on data from a ...
The FDA set a Prescription Drug User Fee act date in the second quarter of 2025 for durvalumab plus chemotherapy in muscle-invasive bladder cancer. A supplemental biologics license application (sBLA) for durvalumab (Imfinzi) plus chemotherapy, as a treatment for patients with muscle-invasive bladder...