Here is a look back at the FDA happenings from the month of October 2022.
In October 2022, the FDA granted 2 approvals for the combination of tremelimumab (Imjudo) and durvalumab (Imfinzi) for patients with unresectable hepatocellular carcinoma (HCC), and teclistamab-cqyv (Tecvayli) in adult patients with relapsed or refractory multiple myeloma.
Across various cancer types, including lymphomas, head and neck cancers, lung cancer, liver cancer, leukemias, and myelomas, the FDA granted 4 fast track designations, 2 biologic license applications, and priority review to the new drug application for quizartinib.
This month, the FDA released their final guidance for developing drugs and biological products for acute myeloid leukemia which address new classes of drugs being developed as alternatives to the standard of care cytotoxic drugs.
The FDA’s Oncologic Drugs Advisory Committee also met to discuss the use of omburtamab in patients with neuroblastoma with central nervous system/leptomeningeal metastases. They ultimately decided that there is not enough evidence to conclude the agent improves overall survival in this patient population and that more research is needed.
FDA Approval Sought for Denileukin Diftitox in Persistent or Recurrent CTCL
On October 3, 2022, the a biologics license application has been submitted to the FDA for denileukin diftitox (formerly E7777, Ontak), a potential treatment option for patients with persistent or recurrent cutaneous T-cell lymphoma.
FDA Grants Fast Track Designation to CUE-101 for Recurrent/Metastatic HNSCC
The FDA granted fast track designation to the interleukin 2 biologic CUE-101 on October 4, 2022, for the treatment of patients with human papillomavirus recurrent/metastatic head and neck squamous cell carcinoma.
FDA Fast Tracks Sapanisertib for NRF2-Mutated Squamous Lung Cancer
Also on October 4, 2022, the FDA granted a fast track designation to sapanisertib (CB-228) for adult patients with unresectable or metastatic squamous non–small cell lung cancer (NSCLC) who harbor a mutation in nuclear factor erythroid 2-related factor (NRF2) and have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy.
FDA Fast Tracks BBP-398 and Sotorasib Combination for Adults With Advanced KRAS G12C+ NSCLC
The FDA granted fast track designation to BBP-398 in combination with sotorasib (Lumakras) for the treatment of adult patients with previously-treated, KRAS G12C-mutated, metastatic NSCLC on October 12, 2022.
FDA Grants Fast Track Designation to TT-101 for Advanced HCC
On October 19, 2022, the FDA granted a fast track designation to TTI-101 as a treatment for patients with relapsed/refractory locally advanced, unresectable, or metastatic HCC.
FDA Approves Durvalumab Plus Tremelimumab for Unresectable HCC
The FDA approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) on October 24, 2022, for the treatment of patients with unresectable HCC.
FDA Grants Priority Review to Quizartinib NDA for FLT3-ITD–Positive AML
Also on October 24, 2022, the FDA granted priority review to the new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for adult patients with newly-diagnosed, FLT3-ITD-positive acute myeloid leukemia.
FDA Grants Accelerated Approval to Teclistamab for Relapsed/Refractory Multiple Myeloma
On October 25, 2022, the FDA granted an accelerated approval to teclistamab-cqyv (Tecvayli) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA Issues Final Guidance on Developing Drugs for Treatment of AML
The FDA released their final guidance for developing drugs and biological products for the treatment of patients with acute myeloid leukemia on October 25, 2022. This focuses on the end points in which sponsors and clinicians should consider when looking at these new agents.
FDA Approval Sought for Epcoritamab as R/R LBCL Treatment
Then on October 28, 2022, a biologics license application was submitted to the FDA, seeking approval of the investigational bispecific antibody, subcutaneous epcoritamab (DuoBody®-CD3xCD20), for the treatment of patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.
ODAC Votes Against Omburtamab for Neuroblastoma with CNS/ Leptomeningeal Metastases
Also on October 28, 2022, the FDA’s Oncologic Drug Advisory Committee voted unanimously that the benefit/risk profile of omburtamab does not have sufficient enough data to support that improves overall survival in patients with neuroblastoma with central nervous system/leptomeningeal metastases.