Jordyn Sava

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.

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.

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.

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.

In an interview with Targeted Oncology, Jacob Stein, MD, MPH, discussed nab-sirolimus and its impact on patients with advanced PEComa.

TYRA-300 showed promising safety and preliminary antitumor activity in FGFR3-altered metastatic urothelial cancer, with a 54.5% partial response rate and 100% disease control in the SURF301 trial.

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

Josep M. Llovet, MD, PhD, discussed the updated data from the LEAP-012 trial in intermediate-stage hepatocellular carcinoma.

Janelle Vicens, DNP, APRN, FNP-BC, and Sandra Sepulveda, AGPNP-BC, MSN, BMTCN, discussed what went into developing this Malignant Hematology and Bone Marrow Transplant APP Fellowship.

In an interview with Targeted Oncology, Erika Hamilton, MD, discussed emerging endocrine therapies that are advancing breast cancer treatment.

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

John Seymour, MD, discusses the development and clinical application of BCL-2 inhibitors for the treatment of CLL.

In an interview with Targeted Oncology, Hina Saeed, MD, discussed how AI and radiomics are changing the landscape of radiation oncology.

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

The FREEDOM2 study demonstrates that fedratinib is an effective second-line treatment for myelofibrosis after ruxolitinib failure or intolerance.

Antonious Hazim, MD, shares insights on his journey into oncology, his experiences at the Mayo Clinic, and his ongoing research.

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

The 0.09 mg/kg dose group of the phase 1 dose-escalation portion of the Acclaim-3 study in extensive-stage small cell lung cancer is completed.

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.