Advancements in Cancer Treatment and Detection Approvals by the FDA in May 2024

Introduction

May 2024 saw noteworthy advancements in several areas, including a significant number of FDA approvals, designations, and clearances related to cancer treatment and detection. The following is a detailed overview of the significant approvals and designations from the FDA.

FDA Approvals for Novel Cancer Therapies

Subcutaneous Formulation of Nivolumab (Opdivo) for Multiple Solid Tumors
Selpercatinib (Retevmo) for the Treatment of Pediatric Patients
ColoSense™, a Noninvasive Stool Test for Colorectal Cancer Screening

The FDA approved several novel cancer therapies like the subcutaneous formulation of nivolumab (Opdivo), for multiple solid tumors, and selpercatinib (Retevmo), for the treatment of pediatric patients aged 2 and older with RET-altered thyroid cancer or solid tumors. ColoSense™, a noninvasive stool test for colorectal cancer screening, was also approved by the FDA in May 2024.

Breakthrough Therapy Designations from the FDA

NVL-655 for ALK-Positive Non-Small Cell Lung Cancer
Inavolisib (GDC-0077) for PIK3CA-Mutated Breast Cancer
SNB-101 for Small Cell Lung Cancer
RAG-01, marking the first small activating RNA drug to receive this status

Promising drugs for specific cancers like NVL-655 for ALK-positive non-small cell lung cancer (NSCLC) and inavolisib (GDC-0077) for PIK3CA-mutated breast cancer received breakthrough therapy designations from the FDA. Several agents gained fast track designations from the FDA, such as SNB-101 for small cell lung cancer and RAG-01, marking the first small activating RNA drug to receive this status.

Biologics License Application of Nivolumab Accepted by the FDA

On May 6, 2024, the biologics license application (BLA) of the subcutaneous formulation of nivolumab co-formulated with human hyaluronidase (rHuPH20) was accepted by the FDA for all previously approved adult solid tumor indications of nivolumab as a monotherapy, monotherapy maintenance following completion of the combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Investigational New Drug Application Cleared by FDA

EIS-12656
BTX-9341
SynKIR-310 for the Treatment of Patients with relapsed/refractory B-cell non-Hodgkin lymphoma

The FDA cleared the investigational new drug application for EIS-12656 for the treatment of patients with various solid tumors, also on May 6, 2024. The FDA cleared an investigational new drug application for BTX-9341 on May 7, 2024, for the treatment of hormone receptor (HR)-positive/HER2-negative breast cancer. The FDA cleared an investigational new drug application for SynKIR-310 for the treatment of patients with relapsed/refractory B-cell non-Hodgkin lymphoma on May 14, 2024.

Fast-Track Designations and Orphan Drug Designations by the FDA

SNB-101
RAG-01
9MW2821
AFM24 Combined with Atezolizumab
VCN-01 for the treatment of patients with metastatic pancreatic adenocarcinoma
AGuIX for treating malignant gliomas and glioblastoma

The FDA granted fast track designation to SNB-101 by the FDA on May 10, 2024, for small cell lung cancer treatment, AFM24 combined with atezolizumab (Tecentriq) for the treatment of patients with advanced and/or metastatic NSCLC without activating EGFR mutations after progression on PD-1/PD-L1 therapy and platinum-based chemotherapy. The FDA granted a fast track designation to RAG-01 by the FDA on May 21, 2024, making it the first small activating RNA drug worldwide to receive this designation. On May 29, 2024, the FDA granted a fast track designation to VCN-01 given in combination with chemotherapy for the treatment of patients with metastatic pancreatic adenocarcinoma. It also granted a fast track designation to AGuIX for treating malignant gliomas and glioblastoma.

Medical Devices Advisory Committee Clearance from the FDA

The FDA’s Medical Devices Advisory Committee gave the green light to the Guardant Health’s Shield blood test for colorectal cancer screening in average-risk adults aged 45 and older on May 23, 2024.

Regenerative Medicine Advanced Therapy Designation by the FDA

The FDA granted regenerative medicine advanced therapy designation to TSC-100 and TSC-101 for the treatment of patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation with reduced intensity conditioning on May 29, 2024.

Conclusion

The above FDA approvals, designations, and clearances bring the hope of new treatments and better chances of recovery for cancer patients worldwide. Further research and development in the cancer treatment and detection field hold the promise of further advancements in the coming years.

Originally Post From https://www.targetedonc.com/view/fda-may-2024-roundup-a-month-of-progress-in-cancer-treatment-and-detection

FDA May 2024 Roundup A Month of Progress in Cancer Treatment and Detection