AMERICAN SOCIETY OF CLINICAL ONCOLOGY

AstraZeneca's Tagrisso recommended for EU approval by CHMP for unresectable EGFR-mutated lung cancer, based on LAURA Phase III trial showing extended median progression-free survival to over three years.

AbbVie's ELAHERE® (mirvetuximab soravtansine) receives European Commission approval for treating platinum-resistant ovarian cancer, marking the first FRα-directed ADC in the EU. ELAHERE demonstrated overall survival benefits in a Phase 3 trial, supported by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay for patient selection.

ELAHERE® (mirvetuximab soravtansine) receives European Commission approval for treating FRα-positive, platinum-resistant ovarian cancer, marking the first ADC therapy in the EU to show overall survival benefit in a Phase 3 trial. The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, used to identify eligible patients, also gets CE Mark.

ELAHERE, a novel therapy for folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer, receives EU approval. It's the first treatment to show overall survival benefit in a Phase 3 trial vs. chemotherapy. The companion diagnostic, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, also gets CE Mark.

Clinicians discussed BTK inhibitor use in CLL, follicular lymphoma, and MCL, focusing on frontline management, sequencing therapies, and managing AEs. They debated treatment options, including BTK inhibitor monotherapy vs. venetoclax and obinutuzumab, and the efficacy of newer BTK inhibitors like acalabrutinib and zanubrutinib. The panel also addressed real-world data on therapy switching and the impact of BTK inhibitors on vaccine responses.

Sanofi announces EMA's CHMP positive opinion recommending Sarclisa approval in combination with bortezomib, lenalidomide, and dexamethasone for transplant-ineligible NDMM patients. A final decision is expected soon. Sarclisa's potential as the anti-CD38 therapy of choice is reinforced.

In a recent program, hematologists Swoboda and Kuykendall discussed current myelofibrosis treatments and potential advancements, focusing on JAK inhibitors and the MANIFEST-2 trial with pelabresib. They emphasized the need for combination therapies and better biomarkers to improve patient outcomes, particularly in spleen volume reduction.

EMA's CHMP recommends Sarclisa + VRd for transplant-ineligible NDMM; Sanofi's Dietmar Berger highlights potential new standard-of-care. FDA approved Sarclisa + VRd for NDMM in 2024. IMROZ phase 3 study supports PFS improvement with Sarclisa + VRd. Sarclisa, a CD38 monoclonal antibody, is approved in over 50 countries for MM treatment.

GSK announces positive results from DREAMM-7 trial showing Blenrep plus BorDex significantly reduces death risk in relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, with full data to be presented at 2024 ASH Annual Meeting.

GSK's DREAMM-7 trial showed belantamab mafodotin + BorDex significantly reduced death risk vs. daratumumab + BorDex in relapsed/refractory multiple myeloma, meeting OS secondary endpoint. Full results to be presented at ASH 2024.