All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.

CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.

ASCP’s Outstanding Education Initiatives Receive Prestigious Awards

July 21st 2023

Two innovative ASCP education initiatives have received accolades from the Alliance for Continuing Education in the Health Professions.

CHMP Supports Approval of Pembrolizumab Plus Trastuzumab/Chemotherapy for HER2+, PD-L1+ Advanced Gastric/GEJ Cancer

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.

Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.

Older Patients Experience Functional Recovery 3 Months After Major Surgery for CRC

July 21st 2023

Three months following a major colorectal cancer surgery, the majority of older patients achieved functional recovery.

First-Line NALIRIFOX Demonstrates Survival Advantage Over Standard Gemcitabine/Paclitaxel in Metastatic PDAC

July 21st 2023

Eileen M. O’Reilly, MD, expands on the updated survival data from NAPOLI-3, explains how NALIRIFOX could fit into the current pancreatic ductal adenocarcinoma treatment paradigm, and shares potential opportunities to build upon this research moving forward.

FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML

July 20th 2023

The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.

Rini Expands on Key Clinical Trial Updates in GU Cancers from the 2023 ASCO Annual Meeting

July 20th 2023

Brian I. Rini, MD, FASCO, highlights key clinical trial updates from the genitourinary cancers landscape presented at the 2023 ASCO Annual Meeting, details the implications of the CONTACT-03 data, expands on the long-term data from the phase 3 KEYNOTE-426 trial in clear cell RCC, discusses findings from the phase 3 TALAPRO-2 trial in patients with metastatic castration-resistant prostate cancer, and more.

APVO436 Plus Venetoclax/Azacitidine Produces Durable Remissions in Relapsed/Refractory AML

July 20th 2023

Treatment with the CD3 x CD123 bispecific antibody APVO436 plus venetoclax and azacitidine led to durable remissions in patients with relapsed/refractory acute myeloid leukemia who had not received prior venetoclax.

ENB-003 Plus Pembrolizumab Elicits Safety, Activity in Ovarian Cancer and Other Advanced, Refractory Solid Tumors

July 20th 2023

Treatment with the combination of ENB-003 and pembrolizumab was well tolerated and produced preliminary signs of clinical activity in patients with platinum-refractory or -resistant, microsatellite stable ovarian cancer, and those with other advanced refractory solid tumors.

Real-World Analysis Shows Brexu-Cel Elicits Higher CR Rate in Patients With R/R MCL Given Fewer Lines of Prior Therapy

July 20th 2023

Nausheen Ahmed, MD, explains the rationale for examining real-world outcomes observed with the use of brexu-cel in the treatment of patients with relapsed/refractory mantle cell lymphoma, details the key efficacy and safety findings from the overall population and different subgroups, and discusses what will be gained with longer follow-up of the study.

Cancer Center of Kansas Joins The US Oncology Network

July 20th 2023

The US Oncology Network announced that the Cancer Center of Kansas has joined The Network by entering into a new managed services partnership.

China’s NMPA Accepts sNDA for First-Line Toripalimab Plus Chemo in ES-SCLC

July 20th 2023

China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.

Tislelizumab Plus Bevacizumab/Chemo Demonstrates Early Efficacy in Cervical Cancer

July 20th 2023

The addition of the PD-L1 inhibitor tislelizumab to standard bevacizumab and platinum-doublet chemotherapy in the first-line setting prolonged progression-free survival, produced encouraging responses, and was well tolerated in patients with cervical cancer.

FDA Awards Fast Track Designation to ARX517 for Metastatic Castration-Resistant Prostate Cancer

July 20th 2023

The FDA has granted fast track designation to ARX517 for use as a potential treatment option in patients with metastatic castration-resistant prostate cancer who experience disease progression on an androgen receptor pathway inhibitor.

Bexmarilimab Plus SOC Continues to Show Early Activity in R/R AML and MDS

July 19th 2023

Bexmarilimab in combination with standard-of-care azacitidine or azacitidine plus venetoclax demonstrated early signs of efficacy in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome.

Agarwal Discusses FDA Approval of Talazoparib Plus Enzalutamide in HRR Gene–Mutated mCRPC

July 19th 2023

Neeraj Agarwal, MD, speaks on the significance of the approval and how the combination of talazoparib and enzalutamide will fit into the treatment landscape of HRR gene–mutated mCRPC.

Diagnostic Advances Distinguish Actionable Drivers of Early Progression in ER+ Breast Cancer

July 19th 2023

Ahmed Elkhanany, MD discusses unmet needs in patients with estrogen receptor–positive breast cancer who progress on frontline therapy, treatment considerations for these patients, and how FES PET imaging may benefit this population.