Hematologic Oncology

A supplemental application has been submitted to Brazil’s health regulatory agency, seeking the approval of tafasitamab for follicular lymphoma.

Here is your guide to all therapeutic options that were approved by the FDA in July 2025 spanning tumor types.

The FDA has issued a complete response letter for odronextamab in relapsed or refractory follicular lymphoma.

Health Canada has expanded the approval of asciminib to include newly diagnosed and pretreated Ph-positive CML.

Francesca Palandri, MD, PhD, discusses findings from a post hoc analysis of momelotinib-induced hemoglobin level improvements in myelofibrosis with anemia.

Austin Kulasekararaj, MBBS, MD, MRCP, FRCPath, and David Dingli, MD, PhD, discuss unmet needs to address in the management of PNH.

Austin Kulasekararaj, MBBS, MD, MRCP, FRCPath, and David Dingli, MD, PhD, discuss implications of data from the APPULSE-PNH trial of iptacopan.

Results of an observational study showed that immunohistochemistry could act as a biomarker for the early detection of TP53‐mutant MDS or AML.

Shyam A. Patel, MD, PhD, and Jonathan M. Gerber, MD, discuss the next steps for validating IHC as a biomarker for TP53 mutations in MDS and AML.

RP1 BLA in advanced melanoma receives CRL from FDA, generic ibrutinib tablets gets green light for B-cell malignancies, and more.

The FDA has approved a generic version of ibrutinib tablets for B-cell malignancies.

Tabelecleucel earned FDA priority review for EBV-positive post-transplant lymphoproliferative disease following a January 2025 complete response letter.

Shyam A. Patel, MD, PhD, and Jonathan M. Gerber, MD, discuss the use of IHC testing for earlier identification of TP53 mutations in MDS and AML.

Austin Kulasekararaj, MBBS, MD, MRCP, FRCPath, and David Dingli, MD, PhD, detail factors for selecting iptacopan in C5 inhibitor–naive and –exposed PNH.

Natural language processing models could help streamline processes within clinical settings.

Stefano Luminari, MD, details the safety profile of odronextamab for the treatment of patients with relapsed/refractory follicular lymphoma.

The oral formulation of decitabine-cedazuridine helps empower patients with MDS or CMML to maintain their quality of life from the comfort of their home.

The European Commission approved obe-cel for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Glofitamab received a CRL from the FDA in R/R DLBCL, ODAC voted against belantamab mafodotin in R/R multiple myeloma, and more.

The FDA issued a CRL to the application for glofitamab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

ICT01 has received orphan drug designation from the FDA for the treatment of patients with acute myeloid leukemia.

Drs Gerber and Patel discuss a study they conducted investigating the use of IHC as a biomarker for early TP53 mutation identification in MDS and AML.

Austin Kulasekararaj, MBBS, MD, MRCP, FRCPath, and David Dingli, MD, PhD, on data for iptacopan in PNH after switching anti-C5 therapy.

Tambiciclib plus azacitidine and venetoclax generated favorable ORR, OS, and safety outcomes in patients with relapsed/refractory acute myeloid leukemia.

In an OncLive Peer Exchange filmed during EBMT, investigators discuss approaches to optimizing allo-HSCT and preventing GVHD in hematologic malignancies.