October 2024 Brief

The application is supported by results from the phase III DESTINY-Breast06 trial.

Acalabrutinib, a BTK inhibitor, has shown promising results in treating mantle cell lymphoma, with the FDA granting it priority review.

The FDA has approved nivolumab plus chemotherapy as a neoadjuvant treatment for operable stage IIA to IIIB non–small cell lung cancer, based on data from the phase 3 CheckMate 77T trial.

The noninvasive test provides a beneficial screening tool for patients 45 and older at average risk for colorectal cancer.

The FDA has granted VLS-1488 fast track designation in patients with platinum-resistant high-grade serous ovarian cancer.

The sponsor is preparing a phase 2 study to evaluate namodenoson in this patient population.

The approval of inavolisib is supported by findings from the phase 3 INAVO120 study evaluating the agent plus palbociclib and fulvestrant.

BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid leukemia.

The phase 3 trial AMPLIFY study plans to test the diagnostic performance of 64Cu-SAR-bisPSMA PET/CT imaging in approximately 220 patients with prostate cancer with biochemical recurrence.

Following promising results from the phase 3 LUNAR trial, the FDA has approved Optune Lua for use with PD-1/PD-L1 inhibitors or docetaxel in patients with metastatic non–small cell lung cancer.

A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.

The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.

The agent is currently being evaluated in a phase 1a study, and a phase 1b/2a study will continue to assess LP-184’s safety and efficacy.

The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal cancer on October 17, 2024.

This approval marks the first CLDN 18.2-targeted therapy in this patient population.

The FDA has approved the Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for treatment with vorasidenib.

The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic hepatocellular carcinoma is supported by the final survival analysis of CARES-310 trial.

The FDA accepted the new drug application for TLX101-CDx and granted priority review to the agent in glioma.

The FDA granted fast track status to HC-7366 for relapsed/refractory AML treatment.

The indication for Jylamvo now includes pediatric patients with acute lymphoblastic leukemia.

Asciminib has gained accelerated approval from the FDA for the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

A new drug application for a 3-month depot formulation of leuprolide mesylate has been submitted to the FDA.

Providers advised to halt use, monitor patients, and report any complications with BioZorb devices to the FDA.

The FDA has lifted clinical holds on trials of zevor-cel, satri-cel, and CT071, and trials will now resume in the US.