August 2024 Brief

Afamitresgene autoleucel is now an FDA-approved treatment for patients with advanced synovial sarcoma.

In an interview with Targeted Oncology, Sandra P. D'Angelo, MD, discussed the approval and supporting data of afamitresgene autoleucel for the treatment of synovial sarcoma.

The FDA has granted PGDx elio plasma focus Dx, the first kitted pan-solid tumor liquid biopsy test for accurate tumor mutation profiling from a blood draw, a de novo marketing authorization.

The FDA has granted an orphan drug designation to alemtuzumab, a chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA has rejected the SIERRA study data for Iomab-B’s biologics license application filing due to insufficient evidence of overall survival improvement.

The FDA has granted approval to vorasidenib for the treatment of patients with IDH-mutant diffuse glioma.

The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.

The FDA has granted 510(k) clearance to the SeCore™ CDx HLA A sequencing system as companion diagnostic for afamitresgene autoleucel in synovial sarcoma, paving the way for a first-of-its-kind solid tumor therapy.

Following voluntary withdrawal in 2014, denileukin diftitox is now available again for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.

A phase 2 trial will assess BRG01 for the treatment of patients with relapsed/metastatic EBV-positive nasopharyngeal carcinoma.

A phase 1b study will investigate PTM-101, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer.

Durvalumab was also granted breakthrough therapy designation for the treatment of patients with limited-stage small cell lung cancer.

Following promising data from the phase 1 Deltacel-01 trial, the FDA has given Deltacel plus low-dose radiation therapy a fast track designation in stage IV non–small cell lung cancer.

A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer.

The FDA-approved regimen is for neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab in patients with resectable non–small cell lung cancer.

The FDA has given positive feedback on the planned phase 3 study for the combination of amezalpat, atezolizumab, and bevacizumab in the first-line treatment of unresectable or metastatic hepatocellular carcinoma.

A Prescription Drug User Fee Act target action date of February 17, 2025, has been set for a decision on the vimseltinib application.

The breakthrough therapy designation is supported by findings from the phase 3 DESTINY-Breast06 study comparing the antibody-drug conjugate with chemotherapy in patients with HR+/HER2-low breast cancer.

PT217 has received an orphan drug designation from the FDA for the treatment of patients with neuroendocrine carcinoma.

The FDA has lifted the partial clinical hold on the phase 1 YL202-INT-101-01 trial, allowing enrollment to resume in the US for patients with advanced NSCLC harboring EGFR mutations and HR-positive/HER2-negative breast cancer.

Lazertinib and amivantamab as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer with specific EGFR mutations demonstrated superior efficacy compared with standard treatment.

Backed by the phase 1 ARTEMIS-001 trial, the FDA has granted GSK5764227 a breakthrough therapy designation for the treatment of extensive-stage small cell lung cancer.

The application is supported by the phase 3 CheckMate -9DW study, and the FDA has set a target action date of April 21, 2025.

The FDA issued a complete response letter for linvoseltamab aimed at treating relapsed/refractory multiple myeloma post multiple therapies.

64Cu-SAR-bisPSMA gained FDA fast track status for advanced prostate cancer imaging.

With this designation, the sponsor of APG-157 is eligible for more frequent interaction with the FDA, facilitating faster drug development and review for this neoadjuvant head and neck cancer therapy.

BGB-16673 has been granted FDA fast track designation based on findings from a phase 1/2 study of the oral agent in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has granted a second orphan drug designation to opaganib in oncology, this time for patients with neuroblastoma.

The FDA’s Oncologic Drug Advisory Committee will meet on September 26, 2024, to discuss PD-L1 cutoffs for immune checkpoint inhibitors in gastric, gastroesophageal, and esophageal cancers.