Sabrina Serani

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.

A new CAR T-cell therapy, durcabtagene autoleucel, showed promising results in treating relapsed/refractory multiple myeloma with high response rates and manageable adverse effects.

For Prostate Cancer Awareness Month, Jeffrey Y.C. Wong, MD, discussed the evolving field of prostate cancer treatment and how it continues to improve.

The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 expression less than 1.

The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 expression less than 1.

Osimertinib is now an FDA-approved therapy for stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations that did not progress during or following platinum-based chemoradiation.

A phase 3 clinical trial studying favezelimab in combination with pembrolizumab for the treatment of patients with previously treated PD–L1-positive metastatic colorectal cancer failed to meet its primary end point of overall survival.

The novel agent LP-184 has been granted rare pediatric disease designations in malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma.

Findings from the phase 3 SIERRA study showed that Iomab-B was associated with a higher durable complete response rate vs allogeneic cell transplant in older patients with relapsed/refractory acute myeloid leukemia.

Analysis of the TROPION-Breast01 study showed that treatment with Dato-DXd did not significantly improve overall survival compared with chemotherapy in HR-positive, HER2-low or -negative breast cancer.

Efficacy findings from the phase 2 AGAVE-201 support the use of axatilimab, which was approved by the FDA for recurrent or refractory chronic graft-vs-host disease in August 2024.