News

JAB-30300, a P53 Y220C activator, received approval from the FDA for its investigational new drug application. A phase 1/2a clinical trial to investigate its safety and efficacy against advanced solid tumors will begin.

In an interview with Targeted Oncology, Reshma Mahtani, DO, discussed findings of a quality improvement initiative identifying challenges for health care professionals and patients with HER2-positive breast cancer.

Here’s a look back on all the FDA happenings from the month of February 2024.

Alice Bertaina, MD, discussed combining T-allo10 gene therapy with stem cell transplants for the treatment of pediatric and young adult patients with hematologic malignancies.

Valentina Ardila, MD, discusses findings from a study investigating the role of obesity in patients undergoing stem cell transplants.

The natural killer cell therapy IDP-023 is being studied in a phase 1 trial for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma.

Raajit K. Rampal, MD, PhD, discusses the MANIFEST-2 trial, a phase 3 study comparing ruxolitinib vs pelabresib and ruxolitinib combined with placebo for the treatment of myelofibrosis.

In an interview with Targeted Oncology, Binod Dhakal, MD, MS, discussed the phase 2 IMPEDE trial, focusing on the treatment regimen Isa-EloPD for patients with relapsed/refractory multiple myeloma.

Ropeginterferon alfa is now a recommended first-line treatment for patients with polycythemia vera, according to the National Comprehensive Cancer Network’s updated guidelines.

Alice Bertaina, MD, discusses combining of T-allo10, a donor-derived cell product, with haploidentical stem cell transplants for the treatment of pediatric and young adult patients with hematologic malignancies.

A fast track designation has been granted to 9MW2821 by the FDA for patients with advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

New guideline favors doublet therapy over triplet for metastatic renal clear cell cancer due to lower toxicity. COSMIC-313 trial shows improved progression-free survival with triplet therapy but significant adverse events.

Experts like Kevin Nead, MD, and Nicholas Leeper, MD, are exploring the connection between cardiovascular disease and cancer.

Approval for melphalan flufenamide has been withdrawn by the FDA due to the failure of its confirmatory trial to demonstrate its clinical benefit and the lack of evidence supporting its safety and effectiveness.

The FDA has granted a breakthrough therapy designation to BAY 2927088 for the treatment of non-small cell lung cancer harboring HER2-activating mutations.

Daniel Cancilla, MD, discusses a study performed at the Cleveland Clinic where a new protocol for plerixafor usage for stem cell transplantation was implemented with the goal of cost savings.

If FDA-approved, epcoritamab would be the first and only subcutaneous bispecific antibody indicated for the treatment of adult patients with relapsed/refractory follicular lymphoma after 2 rounds of previous therapy.

The FDA has accepted the biologics license application of tislelizumab in combination with chemotherapy for the treatment of locally advanced or metastatic gastric or gastroesophageal cancers.

Allina Health Cancer Institute and Astrin Biosciences are jointly integrating AI to improve the assessment of cancer cells in blood samples, beginning with breast cancer, which faces challenges with mammogram imaging and demands innovative solutions.

Peterson discusses the investigation of ruxolitinib in the second line for patients with acute graft-vs-host disease following allogeneic hematopoietic stem cell transplant.

The latest developments across the fields of stem cell transplantation and cellular therapy were presented at the 2024 Tandem Meetings in San Antonio, Texas, from February 21-24, 2024.

The FDA has granted an investigational new drug application to the investigational chimeric antigen receptor T-cell therapy IMC001 for the treatment of EpCAM-positive advanced gastrointestinal tumors.

Orca-T demonstrated survival rates vs post-transplant cyclophosphamide in patients with hematologic malignancies receiving myeloablative conditioning, according to findings from a retrospective analysis.

Improving patient prognostication in mantle cell lymphoma informs treatment decisions and enhances our understanding of the disease's biology.

Promising survival data for Orca-T was also matched in a population of patients with hematologic malignancies aged 55 years and older.

A bounty of FDA drug approvals have arrived plus the pivotal role of cytoreductive therapy and more.

Hedyeh Ebrahimi, MD, MPH, discusses a study that found adding the live bacterial product CBM588 to standard immunotherapy potentially impacted patients' responses in renal cell carcinoma.

Lisocabtagene maraleucel given as a single administration led to rapid responses in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

A retrospective study of real-world patients showed that immune engager therapies had the best response and progression-free survival rates in patients with multiple myeloma who had a relapse after idecabtagene vicleucel treatment.