Sabrina Serani

The FDA has approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics to be used with olaparib, abiraterone, and prednisone or prednisolone BRCA-mutated metastatic castration-resistant prostate cancer.

Findings from the CUPISCO study found that molecularly guided therapy is more effective than standard chemotherapy for patients with unfavorable nonsquamous cancer of unknown primary.

This designation follows the fast track designation that was granted to OBX-115 for the same indication in July 2024.

The phase 3 KEYNOTE-867 and KEYNOTE-630 studies will be stopped due to futility, following analysis from independent data monitoring committees.

The phase 3 study will investigate fezolinetant for vasomotor symptoms in patients receiving adjuvant endocrine therapy.

Christopher Moertel, MD, discussed findings from the phase 2 ReNeu trial of mirdametinib in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

Data from the phase 2 ReNeu study presented at the 2024 ASCO Annual Meeting support this priority review designation.

The innovative bispecific antibody INV724 targets GD2 and B7-H3 with high specificity for 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.

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.

CAR T-cell therapy is a game-changing treatment, but it is not without the potential for serious adverse effects. Researchers and physicians still wonder about the incidence and prevalence of these risks.

Christina Henson, MD, discussed proposed guidelines for head and neck cancer imaging to improve patient outcomes and consistency across practices.

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.

An independent data monitoring committee assessed that the PRECISION1 trial of nab-sirolimus in solid tumors would not meet an efficacy threshold to support the agent’s accelerated approval.

Biagio Ricciuti, MD, discussed findings from a retrospective study exploring the use of immune checkpoint inhibitors for longer than 2 years in patients with non–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.

Byoung Chul Cho, MD, PhD, discussed findings from cohort C of the CHYRSALIS-2 study exploring amivantamab plus lazertinib in patients with non–small cell lung cancer with uncommon EGFR mutations.

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.

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.

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

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

Findings from the phase 3 E1910 study showed that blinatumomab extended overall survival when added to chemotherapy vs chemotherapy alone in B-cell precursor acute lymphoblastic leukemia.

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

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

Moritz Fürstenau, MD, discussed a follow-up of the GAIA/CLL13 study exploring venetoclax combinations vs chemoimmunotherapy for the treatment of chronic lymphocytic leukemia.

Selpercatinib led to high response and progression-free survival rates among patients who were treatment naive and pretreated with RET-altered thyroid cancers.

Erin E. Hahn, PhD, MPH, discussed the findings and implications of a retrospective study exploring breast cancer surveillance in pre- and post-COVID periods.

The blood-based ctDNA test delivered high rates of sensitivity and specificity with long lead times in detecting minimal residual disease in patients with colorectal cancer.

A phase 2 study found that a combination of pacritinib, sirolimus, and tacrolimus successfully suppressed pSTAT3 and Th1/Th17 cells, but failed to prevent acute graft-versus-host disease following allogeneic transplant.

Isatuximab plus VRd induction before transplant led to better progression-free survival compared with VRd alone, according to data from the GMMG-HD7 phase 3 study.