Sabrina Serani

The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.

Holly Pederson, MD, and Elisha Hughes, MD, discussed the use of a polygenic risk score to identify why Black women incur higher rates of triple-negative breast cancer at younger ages.

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

Zanubrutinib, obinutuzumab, and venetoclax delivered promising response and survival data for the treatment of patients with mantle cell lymphoma harboring a TP53 mutation.

Findings from 3 quality improvement initiatives presented at the ACCC National Oncology Conference shed light on the feasibility and importance of these projects at the community level.

ADRX-0405 is a novel antibody-drug conjugate targeting STEAP1, and a phase 1a/b study will investigate the agent for the treatment of advanced solid tumors.

Rebecca A. Shatsky, MD, discussed the I-SPY2.2 trial, its novel design, and its implications for the treatment of patients with breast cancer.

Gilead, manufacturer of the TROP2-directed antibody-drug conjugate sacituzumab govitecan, made the decision to withdraw the agent in consultation with the FDA.

Bertram Yuh, MD, MISM, MSHCPM, discussed how single-port robotic surgery has changed treatment paradigms for patients with prostate cancer.

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

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

The completion of a new drug application for the combination of avutometinib and defactinib in KRAS-mutant ovarian cancer is expected to be finalized with the FDA by the end of the month.

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.

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

A new combination therapy of lurbinectedin and atezolizumab showed promising results in improving overall survival and progression-free survival in extensive-stage small cell lung cancer.

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

Meredith McKean, MD, MPH, discussed findings from a longer-term follow-up study evaluating fianlimab plus cemiplimab for the treatment of metastatic melanoma.

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

According to findings from the TALAPRO-2 study, the combination led to significant and meaningful improvements in overall survival vs enzalutamide monotherapy.

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

The first patient in a phase 1/2 trial investigating a novel agent for the treatment of non–small cell lung cancer has been dosed.

The KEYNOTE-689 study evaluating pembrolizumab in this patient population met its primary end point of event-free survival.

Ana Baramidze, MD, PhD, discussed 5-year follow-up results from the EMPOWER-Lung study evaluating cemiplimab vs chemotherapy in advanced first-line non–small cell lung cancer.

The final analysis of the phase 3 PANTHER study confirmed survival benefits for patients receiving dose-dense vs standard chemotherapy.

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

For Breast Cancer Awareness Month, Oranus Mohammadi, MD, discussed the remarkable progress made in improving survival rates for patients with breast cancer.

The 2024 International Myeloma Society Annual Meeting was a groundbreaking event that showcased the latest advancements in multiple myeloma research and treatment.

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

Here is a look back on all the FDA happenings from the month of September 2024.

Results from cohort 2 of the TROPHY-U-01 study showed that sacitizumab govitecan led to rapid responses in patients with locally advanced or metastatic urothelial carcinoma.