EP. 1: FDA Approves Pirtobrutinib in CLL and SLL
The FDA has granted accelerated approval to pirtobrutinib for the treatment of patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
EP. 2: FDA Receives IND for GTB-3650 in CD33+ AML and MDS
A phase 1 trial plans to be initiated in 2024 to investigate GTB-3650 for the treatment of patients with CD33-positive leukemia.
EP. 3: FDA Clears IND for CT071 in RRMM and Primary Plasma Cell Leukemia
CT071, a chimeric antigen receptor T-cell therapy candidate, had an investigational new drug application cleared by the FDA for patients with relapsed/refractory multiple myeloma and primary plasma cell leukemia.
EP. 4: FDA Grants Priority Review to Nivolumab Plus Chemotherapy in mUC
Summary: The FDA has accepted for priority review nivolumab and cisplatin-based chemotherapy as a first line of treatment in patients with inoperable or metastatic urothelial carcinoma.
EP. 5: Mirvetuximab sBLA Receives FDA Priority Review in Ovarian Cancer
The FDA has granted priority review to the supplemental biologics application of mirvetuximab soravtansin-gynx for the treatment of patients with platinum-resistant ovarian cancer.
EP. 6: FDA Grants BTD to TAR-200 in Bladder Cancer Subset
TAR-200, a novel targeted therapy, has been granted breakthrough therapy designation by the FDA in high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.
EP. 7: FDA Grants 2 Designations to Cretostimogene Grenadenorepvec in NMIBC
The FDA has granted 2 designations to cretostimogene grenadenorepvec, an oncolytic immunotherapy, for the treatment of a specific type of high-risk bladder cancer:
EP. 8: FDA Clears IND for VIPER-101 in T-Cell Lymphoma
An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.
EP. 9: FDA Grants Priority Review to Tarlatamab in Advanced SCLC
The FDA has granted priority review to tarlatamab for advanced small cell lung cancer based on encouraging results in a phase 2 clinical trial.
EP. 10: FDA Approves Eflornithine to Reduce Risk of Relapse in High-Risk Neuroblastoma
The FDA has approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
EP. 11: FDA Approves Belzutifan for Adult Patients With Advanced RCC
Belzutifan is now an FDA-approved treatment for adult patients with advanced renal cell carcinoma.
EP. 12: FDA OKs Enfortumab Vedotin/Pembrolizumab Combo for Advanced Urothelial Cancer
The FDA has granted approval to the combination of enfortumab vedotin-ejfv and pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer.
EP. 13: FDA Issues CRL to Cosibelimab in Metastatic or Locally Advanced CSCC
The FDA has issued a complete response letter which will delay the potential approval of cosibelimab for patients with cutaneous squamous cell carcinoma.
EP. 14: FDA Clears Investigational New Drug Application of AVS100 in Solid Tumors
The FDA has granted clearance to a promising new agent, AVS100, for a phase 1 trial to target solid tumors.
EP. 15: FDA Clears IND of Padeliporfin VTP in Unresectable PDAC
A phase 1 study investigating padeliporfin vascular targeted photodynamic in patients with unresectable pancreatic adenocarcinoma will begin following the FDA clearance of an investigational new drug application.
EP. 16: FDA Considers First-Line Amivantamab Plus Lazertinib in EGFR+ NSCLC
The FDA is considering 2 applications for amivantamab plus lazertinib as a first-line treatment for EGFR-mutated non–small cell lung cancer, based on the phase 3 MARIPOSA study.
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