The FDA has extended its review of zenocutuzumab's in NRG1+ NSCLC and PDAC to February 2025, with efficacy and safety data from the eNRGy trial supporting the application.

Casdatifan showed notable clinical activity and an acceptable safety profile in treating patients with metastatic clear cell renal cell carcinoma.

Despite regulatory challenges from the FDA, odronextamab has received European approval for the treatment of patients with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma following 2 prior treatments.

In an interview, Colton Ladbury, MD, discussed new insights from a study and expanded on total marrow irradiation’s potential to transform transplant conditioning.

The study is evaluating AJ1-11095, a novel agent for the treatment of myelofibrosis that did not respond to or relapsed following treatment with a type I JAK2 inhibitor.

Domenica Lorusso, MD, PhD, discussed the KEYNOTE-A18 trial, its findings, and implications for oncologists.

Three phase 3 trials of combinations including datopotamab deruxtecan for the treatment of non–small cell lung cancer are beginning.

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

Hamlet Gasoyan, MD, discussed the implications of a multiple myeloma study’s findings and their potential impact on clinical practice and patient outcomes.

Aumolertinib showed improved PFS in NSCLC and ivonescimab outperforms pembrolizumab in advanced cases. Plus, insights into CAR T-cell therapy and its associated AEs are discussed in relapsed multiple myeloma.

A phase 2/3 study investigating uproleselan with standard 7+3 chemotherapy in newly diagnosed, older patients with acute myeloid leukemia did not achieve the primary end point of improved event-free survival.

David Sallman, MD, discussed the challenges and new studies of high-risk myelodysplastic syndrome therapies.

The FDA recently approved the combination of inavolisib, fulvestrant, and palbociclib in this patient population.

Barbara O’Brien, MD, discussed findings and implications from the phase 2 TBCRC049 study evaluating the combination of tucatinib, trastuzumab, and capecitabine in HER2-positive breast cancer with leptomeningeal metastasis.

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

In an interview with Targeted Oncology, Josep Maria Ribera, MD, PhD, discussed the evolving treatment protocols for Philadelphia chromosome-positive acute lymphoblastic leukemia.

Nazli Dizman, MD, discussed the current measures for enforcing ASCO’s language of respect guidelines in the renal cell carcinoma space.

In this episode of Targeted Talks, Seth Wander, MD, PhD, discusses the clinical importance of ESR1 mutations in HR-positive metastatic breast cancer and how these mutations influence treatment approaches.

Noah S. Kalman, MD, MBA, highlighted advancements in thyroid cancer treatment, emphasizing personalized therapies, molecular testing, and optimizing traditional approaches.

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

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

A phase 1 study of tapotoclax in high-risk myelodysplastic syndromes demonstrated the agent was tolerable but showed limited efficacy.

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

In an interview with Targeted Oncology, Peter Schmid, MD, PhD, discussed the results from the phase 3 KEYNOTE-522 trial.

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.